Treatment Trials

321 Clinical Trials for Various Conditions

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RECRUITING
Establishing Baseline Sysmex UF-5000 Flow Cytometer Results in Healthy Men
Description

Acute urethritis (inflammation of the male urethra) affects millions of men in the United States each year. Effective management of STIs is complicated by asymptomatic infections, as men often delay seeking care until symptoms become severe. Yet, even men without symptoms can show measurable evidence of urethritis. Therefore, a cheap, simple, and non-invasive point-of-care (POC) test, providing results within 30 minutes, could significantly enhance STI management by facilitating early diagnosis and treatment. A new diagnostic method, urine flow cytometry, has shown potential in hospital settings for accurately detecting inflammation by counting white blood cells (infection-fighting cells) in urine samples. The Sysmex UF-5000 flow cytometer, a state-of-the-art device, may offer a non-invasive, cost-effective, and accurate method to diagnose urethritis compared to traditional Gram stains and urinalysis, potentially extending its use beyond specialized clinics. This study aims to determine the efficacy and precision of the Sysmex UF-5000 analyzer in diagnosing urethritis using first-catch urine samples. Additionally, the study seeks to evaluate whether urine collected using the 10 mL Colli-Pee device provides greater accuracy and precision compared to the standard urine cup (30-60 mL) when used with urine flow cytometry and LE urinalysis.

ACTIVE_NOT_RECRUITING
A Crossover Clinical Trial Investigating the Effects of Geranylgeraniol (GG) Supplementation on Testosterone Levels in Healthy Men and Women Over an 18-week Period
Description

The primary purpose of this study is to investigate the effects of geranylgeraniol (GG) supplementation on testosterone levels in middle-aged (40 to 65 years) healthy men and women. The research team hypothesizes that geranylgeraniol (GG) supplementation will enhance testosterone levels and improve self-reported health outcomes in a healthy population.

Conditions
COMPLETED
A Clinical Study of MK-6552 and Modafinil in Healthy Men (MK-6552-005)
Description

The goal of this study is to learn what happens to MK-6552 in a person's body over time. Researchers will compare what happens to levels of MK-6552 in people's blood when it is taken with and without modafinil. Researchers also want to learn about the safety of MK-6552 taken with and without modafinil and if people tolerate it.

COMPLETED
A Pharmacokinetic Study of a Novel Nutritional Product on Healthy Men and Women
Description

This study is a randomized, double-blind, placebo-controlled study of N=16 apparently healthy men and women. The purpose of this study is to examine the bioavailability of a health and wellness supplement.

Conditions
RECRUITING
The Impact of a Plant-based Meat Meal Versus an Animal Meat Meal on Erectile Function in Healthy Men.
Description

The goal of this study is to determine whether erectile function is differentially impacted by a single plant-based meat meal versus a single animal meat meal in healthy men with normal erectile function.

RECRUITING
Role of Ashwagandha Extract (Capsule KSM-66 300 mg) in Improving Sexual Health in Healthy Men
Description

The clinical study aims to evaluate Efficacy and Safety of KSM66 Ashwagandha Standardized Root Extract for Improving Sexual Health in Healthy Men by measuring sex hormone levels in participant's blood, analyzing results of questionnaires, and monitoring adverse events in the post-marketing phase. Changes in the sex hormone levels in blood may affect sexual health or sexual health satisfaction. Efficacy is defined as increase in sex hormone levels in blood, and improvement in results or scores of assessment questionnaires.

Conditions
COMPLETED
Assessment of the Efficacy of Carnipure® AAS on Body Composition, Muscle Thickness, and Strength Adaptations in Healthy Men
Description

This study is a 12-week randomized active control trial that is investigating the effects of Carnipure(R) AAS on muscle hypertrophy, body composition, and muscular strength adaptations in healthy men performing a resistance training program.

COMPLETED
A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation II
Description

In this study, the study drug 'NNC0385-0434' will be tested in 3 different tablet formulations. These formulations are being tested for the treatment of hypercholesterolemia (high cholesterol). Participants will only receive 2 of the 3 tablet formulations. The treatments participants get are decided by chance. Participants will receive 1 formulation for 10 days (first treatment period) and the other formulation for 5 days (second treatment period). The study will last up to 96 days. Only men can participate in this clinical study.

COMPLETED
Binding and Effects of Lu AG06466 in the Brain of Healthy Men
Description

This study is being done to learn about the binding of Lu AG06466 and its major breakdown product (Lu AG06988) in the brain of healthy men having received multiple doses of Lu AG06466. As the binding will result in inhibition of an enzyme in the endocannabinoid system called monoacylglycerol lipase (MAGL), the effects on this system will be evaluated both in the blood and cerebrospinal fluid and compared to the binding in the brain.

COMPLETED
A Study to Learn How [14C]ASP0367 is Processed by the Body in Healthy Men
Description

ASP0367 is a potential new treatment for people with Duchenne Muscular Dystrophy and Mitochondrial Myopathies. Before ASP0367 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. This study is in healthy men. The main aim of this study is to learn how ASP0367 is processed by and acts upon the bodies of healthy men. To do this, \[14C\] which is a certain chemical (called a tracer, or radionuclide) has been added to ASP0367. \[14C\] gives off radiation, but the dose is very low (about the same as the dose from an x-ray) and will leave the body within a few days. \[14C\] will be picked up by a scanner and will be used to follow ASP0367 through the body. \[14C\]ASP0367 will be a liquid. During the study, the men who take part will stay in the clinic for 6 days and 5 nights. Some men may need to stay up to an extra 7 days in the clinic. This will happen if there is a medical reason or if they still have traces of radiation in their blood, urine or feces. On the day before they drink \[14C\]ASP0367, the men will be asked about their medical history, have a medical examination, and have their vital signs checked (blood pressure and pulse). They will also have an ECG to check their heart rhythm. They will give urine, stool and blood samples for laboratory tests. They will also be asked if they have had any medical problems. The men will fast for 10 hours or more before drinking \[14C\]ASP0367 and for 4 hours afterwards. They will only have one drink of \[14C\]ASP0367. They will need to lie still for 4 hours after drinking \[14C\]ASP0367. They will have their vital signs checked and give urine, stool and blood samples for laboratory tests. Then, they will give urine, stool and blood samples every day until they leave the clinic. They will also be asked every day if they have had any medical problems. The day after they drink \[14C\]ASP0367, the men will also have an ECG. On the last clinic day, the men will also have a physical exam, have their vital signs checked and have an ECG. The men can leave the clinic once \[14C\]ASP0367 has left the body and they have no medical problems. About 10 days later, the clinic will call the men to check if there were any further medical problems. No other visits are planned during this study.

COMPLETED
Drug Drug Interaction Study With Lu AG06466 in Young Healthy Men
Description

The purpose of this study is to evaluate the effect of repeated doses of the drug Lu AG06466 on the exposure of metoprolol, midazolam and bupropion

Conditions
COMPLETED
Study to Evaluate and Compare the PK Profiles of Abaloparatide-SC and Abaloparatide-sMTS in a Cohort of Healthy Men and Healthy Women.
Description

A study to evaluate and compare the PK profiles of abaloparatide-SC 80 μg and abaloparatide-sMTS 300 μg in a cohort of healthy men and to make a similar evaluation in a cohort of healthy women

COMPLETED
A Study in Healthy Men to Test Whether BI 409306, BI 425809 or Lamotrigine Can Reverse the Memory Problems Caused by Ketamine
Description

The main objective of this trail is to investigate if and to what extent BI 409306, BI 425809 and lamotrigine attenuate ketamine induced cognitive deficits.

Conditions
COMPLETED
Study That Evaluates the Effect of CYP3A4 Inhibition on Lu AG06466 in Healthy Men and Women
Description

A study to learn how a drug (itraconazole) that is known to inhibit a certain enzym in the liver, impacts the body's ability to breakdown Lu AG06466 into breakdown products in healthy men and women. The main breakdown product is Lu AG06988.

Conditions
COMPLETED
NEM® + KD PUR® Fish Oil Versus Placebo in Exercised-induced Joint Pain, Stiffness, & Cartilage Turnover in Healthy Men & Women
Description

This study is intended to evaluate the effect of the dietary supplement combination of NEM® brand eggshell membrane + KD PUR® brand fish oil versus placebo in reducing exercise-induced joint pain, stiffness \& cartilage turnover in healthy men \& women. Half of the study participants will receive NEM + fish oil, once daily, orally while the other half of the study participants will receive placebo, once daily, orally while performing an exercise regimen every other day for two weeks.

COMPLETED
Determination of Pre-Absorptive Dissociation of Zinc From a Zinc Amino Acid Complex in Healthy Men
Description

Zinc may be absorbed from diet via zinc transporter mediated pathways, or, when coupled with amino acids, via amino acid transporter pathways. When zinc is coupled with amino acids in diet, it may dissociate from those amino acids in the acidic environment of the stomach prior to entering the small intestine. An experimentally-determined value for any pre-absorptive dissociation of zinc from a zinc amino acid complex (ZnAA) is necessary for the accurate compartmental modeling of zinc metabolism when provided as ZnAA compared with ionic zinc, which the investigators will perform in a future study. The current study will allow us to determine the dissociation of zinc from ZnAA, while serving as a pilot test of a novel technique to determine for the first time an individual's zinc transport kinetics.

COMPLETED
NEM® + BIOCURC® Versus Placebo in Exercised-induced Joint Pain, Stiffness, & Cartilage Turnover in Healthy Men & Women
Description

This study is intended to evaluate the combined effects of the dietary supplement NEM® brand eggshell membrane and BIOCURC® brand bioavailable curcumin versus placebo in reducing exercise-induced joint pain, stiffness \& cartilage turnover in healthy men \& women. Half of the study participants will receive NEM+BIOCURC, once daily, orally while the other half of the study participants will receive placebo, once daily, orally while performing an exercise regimen every other day for two weeks.

COMPLETED
The Safety and Intake Rate of a Natural Compound Arctigenin in Healthy Men
Description

The purpose of this research study is to determine if consuming arctigenin, a natural compound from a Chinese herb called Arctium lappa (commonly called greater burdock), is safe, and to measure the intake level of arctigenin in blood. Arctigenin is being studied by researchers for potential health benefits such as helping to lower the risk of inflammation and cancer. A human study has been done measuring the uptake of arctigenin into blood after consumption of the herb extract containing arctigenin, and found no toxicity. Studies in mice demonstrated that consumption of arctigenin in pure form at a safe level is highly effective in inhibition of prostate cancer growth. Therefore, this study is designed to evaluate the safety and uptake rate of pure arctigenin in humans, which may be potentially used in the future for prostate cancer prevention.

Conditions
COMPLETED
NEM® Versus Placebo in Exercised-induced Joint Pain, Stiffness, & Cartilage Turnover in Healthy Men & Women
Description

This study is intended to evaluate the effect of the dietary supplement NEM® brand eggshell membrane versus placebo in reducing exercise-induced joint pain, stiffness \& cartilage turnover in healthy men \& women. Half of the study participants will receive NEM, once daily, orally while the other half of the study participants will receive placebo, once daily, orally while performing an exercise regimen every other day for two weeks.

COMPLETED
Zinc Supplement Before or With Food in Generally Healthy Men
Description

The purpose of this study is to determine the influence of food consumption timing on the body's response to a zinc supplement

COMPLETED
First Research Study of the Possible New Medicine NNC0113-2023 in Healthy Men.
Description

The aim of this study is to assess how safe the study drug is and how well a participant tolerates it after a single oral (taken by mouth) dose. The study also aims to measure the concentration of the study drug and its breakdown products after a single dose. Participants will either get NNC0113-2023 (a new medicine) or placebo (a "dummy medicine similar to the study medicine but without active ingredients) - which treatment any participant gets is decided by chance. Participants will get one dose (can be one or two tablets) of study medicine. The study will last for about 65 days. Participants will have 10 scheduled site visits with the study physician or study staff at the study centre. For one of the visits, participants will stay at the research unit for 5 days. At all visits, except the first information visit, participants will have blood drawn along with other clinical assessments. Participants cannot take part in this study if participants have any disorder that the doctor thinks is a health problem. Only healthy men are allowed to take part.

ACTIVE_NOT_RECRUITING
MitoQ Supplementation and Cardiovascular Function in Healthy Men and Women
Description

In this pilot study, the investigators will determine whether supplementation with a mitochondrial-targeted antioxidant (Mitoquinone (MitoQ)) improves mitochondrial function, left ventricular diastolic and vascular function.

UNKNOWN
28-Day Repeat-Dose, Dose Escalation Study of 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) in Healthy Men
Description

This is a Phase I multicenter, double-blind, repeat dose, dose-escalating study, in healthy men to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC).

COMPLETED
Study to Evaluate the Acute Bioavailability of EPA and DHA From a DietarySupplement in Healthy Men and Women
Description

The objective of this study was to evaluate and compare the acute bioavailability of EPA and DHA in wax ester form provided as a dietary supplement compared to a well-studied and defined ethyl ester formulation in generally healthy men and women.

Conditions
UNKNOWN
Single Dose, Dose-Ranging Study of 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) in Healthy Men
Description

The long term objective is to develop a new male hormone 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) as a male hormonal contraceptive.

COMPLETED
Study to Evaluate Pharmacokinetics of Prototype Modified-Release Formulations Of Apremilast in Healthy Men
Description

This study will assess up to 12 different oral formulations of apremilast to determine how much apremilast is absorbed by the body compared to a reference formulation.

COMPLETED
Safety and Pharmacokinetic (PK) Study to Assess Bronchopulmonary Disposition of IV Eravacycline (TP-434) in Healthy Men and Women
Description

This is a phase 1, open-label, randomized pharmacokinetic and safety study in healthy adult subjects, who will undergo bronchoscopy and bronchoalveolar lavage (BAL) after receiving seven (7) doses of 1.0 mg/kg IV TP-434.

COMPLETED
Study to Evaluate the Concentration of Denosumab in Seminal Fluid in Healthy Men After a Single Subcutaneous Dose
Description

This is a phase 1b, open-label, single dose study in healthy male subjects. Approximately 12 healthy male subjects will receive a subcutaneous injection of denosumab on Day 1. Subjects will be followed by a 105 day treatment-free follow-up period.

COMPLETED
A Study to Define the ECG Effects of Tizanidine Compared to Placebo and the Positive Control, Moxifloxacin, in Healthy Men and Women Using a Blinded ECG Evaluator: A Thorough ECG Trial
Description

This is a single-center, partial-blind, randomized, placebo-controlled, parallel design study with a nested crossover comparison to define the ECG effects of tizanidine compared to placebo and the positive control, moxifloxacin, in healthy men and women. The study will be conducted in a Phase 1 unit with sufficient facilities to house subjects as required by the protocol.

Conditions
COMPLETED
The Effect of Mixed Exercise and Metabolic Stress in Relationship to Age in Healthy Men
Description

Aging in men reduces the amount of luteinizing hormone (LH) and testosterone (Te) secreted in each burst. Stress-associated mechanisms introduced by acute illness and chronic disease decrease LH and Te secretion further. A major unresolved issue is whether the aging process heightens the negative effects of a stressor (whether physical or metabolic) upon LH and Te secretion. This study will assess LH and Te secretion in response to a physical stressor (maximal exercise) and a common metabolic stressor (hyperglycemia) as a function of age in healthy men ages 18-80 yr.

Conditions