COMPLETED

Study of Single Oral Doses of HOPO 14-1 Evaluating Safety, Tolerability, Pharmacokinetics

Conditions

Toxicity;Chemical Internal Radionuclide Contamination

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The study objectives are to define the safety and tolerability profile of oral, single ascending dose (SAD) levels of HOPO 14-1 capsules in cohorts of healthy participants and to assess the pharmacokinetic (PK) and excretion profile of HOPO 14-1. The study hypothesis is that a single dose of HOPO 14-1 will be safe and tolerable up to 7500 mg.

Official Title

An Open-Label, First-In-Human Study of Single Oral Doses of HOPO 14-1 Evaluating Safety, Tolerability, Pharmacokinetics, and Excretion in Healthy Participants

Quick Facts

Study Start:2023-03-15

Study Completion:2025-08-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05628961

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Ability of participant to understand the requirements of the study, provide written informed consent, and agree to abide by the study requirements * Agree to use contraception from time of screening until 14 days after dosing (Day 14) if female is of childbearing potential or male is with female partner of childbearing potential. * In good general health based on medical history, physical examination (PE), and screening evaluations. * Negative urine screen for drugs of abuse (except if participant provides prescription justifying use prior to urine screen). * Body weight ≥ 50 kilogram (kg) and ≤ 110 kg. If body weight is over 110 kg, then body mass index (BMI) will be considered and must be ≤ 40 kg/m\^2.	* Inability or unwillingness of a participant to give written informed consent or comply with study protocol. * Any hematology, chemistry, coagulation, or urinalysis value on screening labs defined in the United States Food and Drug Administration (FDA) Guidance for Industry Toxicity Grading Scale as Grade 1 or higher. * Any clinically significant electrocardiogram (ECG) abnormality * Pregnant or breastfeeding * Active substance abuse or history of any medical or psychiatric condition that would jeopardize the participant's safety or the participant's ability to comply with the protocol. * Received an organ transplant (solid or bone marrow). * Received a blood transfusion within 3 months of dosing. * Difficulty swallowing tablets or capsules. * Febrile illness or significant infection within 7 days of dosing. * Symptoms of hypotension (lightheadedness, syncope, balance disturbances, or extreme fatigue) within 48 hours of dosing. * Hepatitis B virus surface antigen (HBsAg) positive or serologic (antibody positive) evidence of infection with hepatitis C virus (HCV) or human immunodeficiency virus (HIV). * Tested positive for SARS-CoV-2 (COVID-19) within 21 days of dosing. * Chelation therapy (e.g., ethylenediaminetetraacetic acid \[EDTA\], diethylenetriamine pentaacetate \[DTPA\]) in the past year. * Use of laxatives, antibiotics, and/or antacids within 7 days of dosing. * Use of investigational drugs within 60 days of dosing or 5 half-lives, whichever is longer. * Received a vaccination within 30 days of dosing. * Potential allergic reaction to product (oleic acid or HOPO 14-1 product). * Past or current medical problems or findings from physical examination (PE) or laboratory testing

Inclusion Criteria

Exclusion Criteria

* Ability of participant to understand the requirements of the study, provide written informed consent, and agree to abide by the study requirements
* Agree to use contraception from time of screening until 14 days after dosing (Day 14) if female is of childbearing potential or male is with female partner of childbearing potential.
* In good general health based on medical history, physical examination (PE), and screening evaluations.
* Negative urine screen for drugs of abuse (except if participant provides prescription justifying use prior to urine screen).
* Body weight ≥ 50 kilogram (kg) and ≤ 110 kg. If body weight is over 110 kg, then body mass index (BMI) will be considered and must be ≤ 40 kg/m\^2.

* Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
* Any hematology, chemistry, coagulation, or urinalysis value on screening labs defined in the United States Food and Drug Administration (FDA) Guidance for Industry Toxicity Grading Scale as Grade 1 or higher.
* Any clinically significant electrocardiogram (ECG) abnormality
* Pregnant or breastfeeding
* Active substance abuse or history of any medical or psychiatric condition that would jeopardize the participant's safety or the participant's ability to comply with the protocol.
* Received an organ transplant (solid or bone marrow).
* Received a blood transfusion within 3 months of dosing.
* Difficulty swallowing tablets or capsules.
* Febrile illness or significant infection within 7 days of dosing.
* Symptoms of hypotension (lightheadedness, syncope, balance disturbances, or extreme fatigue) within 48 hours of dosing.
* Hepatitis B virus surface antigen (HBsAg) positive or serologic (antibody positive) evidence of infection with hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
* Tested positive for SARS-CoV-2 (COVID-19) within 21 days of dosing.
* Chelation therapy (e.g., ethylenediaminetetraacetic acid \[EDTA\], diethylenetriamine pentaacetate \[DTPA\]) in the past year.
* Use of laxatives, antibiotics, and/or antacids within 7 days of dosing.
* Use of investigational drugs within 60 days of dosing or 5 half-lives, whichever is longer.
* Received a vaccination within 30 days of dosing.
* Potential allergic reaction to product (oleic acid or HOPO 14-1 product).
* Past or current medical problems or findings from physical examination (PE) or laboratory testing

Contacts and Locations

Study Locations (Sites)

SRI International Clinical Trials Unit

Plymouth, Michigan, 48170

United States

Collaborators and Investigators

Sponsor: SRI International

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-15

Study Completion Date2025-08-04

Study Record Updates

Study Start Date2023-03-15

Study Completion Date2025-08-04

Terms related to this study

Keywords Provided by Researchers

Internal Radionuclide Contamination

Additional Relevant MeSH Terms

Toxicity;Chemical