COMPLETED

First-in-Human Trial in Healthy Adult Volunteers to Evaluate Safety, Tolerability and PK of LAPIX Study Drug; LPX-TI641

Conditions

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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

A Phase I First-in-Human, Randomized, Double-Blind, Placebo-Controlled Study in Healthy Adult Volunteers to Evaluate Safety, Tolerability, and Pharmacokinetics after Single and Multiple Oral Dose of LPX-TI641.

Official Title

A Phase I First in Human, Randomized, Double-blind, Placebo- Controlled Study in Healthy Adult Volunteers to Evaluate Safety, Tolerability and Pharmacokinetics of LPX-TI641 After Single and Multiple Oral Doses.

Quick Facts

Study Start:2023-10-30

Study Completion:2024-11-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05853835

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 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. Subject has signed an Informed Consent Form (ICF) prior to any study-specific procedures being performed 2. Healthy volunteers (HV) with no known acute or chronic medical conditions (respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, endocrine, etc.) at the time of enrollment. 3. Healthy volunteers (HV) with dermatological conditions are allowed if they are not receiving systemic treatments for their dermatological condition. 4. All male and non-pregnant females aged 18-55 years old irrespective of their race and ethnicity. 5. Body Mass Index (BMI) 18.0-30.0 kg/m2, inclusive at screening. 6. Clinical laboratory evaluations performed at screening, are within acceptable normal reference ranges (Grade 1 abnormalities may be acceptable if deemed necessary by the investigator. Grade 2 or higher would be exclusionary). 7. Subjects who are willing and able to adhere to study protocol requirements including but not limited to scheduled outpatient visits, inpatient hospital stay, laboratory tests, and 12-lead ECG. 8. Contraception - All subjects (male and female) must agree to use any two of the highly effective contraception methods listed below. This criterion must be followed from the time of the first dose of study medication for 6 weeks after the last dose in females and for 90 days after the last dose for males.	1. Any known history of malignancy 2. Any known history of asthma 3. COVID-19: 4. Subject with positive results for HBsAg (hepatitis B surface antigens) and/or HBcAb (Hepatitis B core antibodies) and/or HCV Ab (hepatitis C antibodies), and/or HIV Ab (human immunodeficiency virus antibodies). 5. Blood loss of \>250 mL or donated blood within 56 days or donated plasma within 7 days of screening. 6. Recent vaccination with live attenuated vaccines such as influenza, MMR, Herpes zoster, varicella, yellow fever, Rotavirus vaccine, etc., or inactivated vaccines such as Hepatitis A, Rabies vaccine, etc. in the past 30 days. 7. Abnormal amylase levels (Grade 2 or greater) 8. Clinically significant ECG abnormalities (QTcF \>450 ms for males and QTcF \>470 ms for females). 9. History of or current compulsive abuse of alcohol or positive test for alcohol at screening or Day 0 of Visit 1 10. History of or current use of or positive test at screening or Day 0 of Visit 1 for drugs such as marijuana, cocaine, phencyclidine \[PCP\], crack, opioid derivatives including heroin, and amphetamine derivatives. 11. Consumption of any beverages or food containing alcohol or drugs such as marijuana, cocaine, phencyclidine \[PCP\], crack, opioid derivatives including heroin, and amphetamine derivatives from screening until donating the last sample of the study 12. Use of medications for the timeframes specified below, except for medications exempted by the Investigator on a case-by-case basis because they are judged unlikely to affect the PK profile of the study drug or subject safety (e.g., topical drug products without significant systemic absorption): * prescription medications within 14 days prior to dosing or 5 half-lives, whichever is longer; * over-the-counter products and natural health products (including herbal remedies homeopathic and traditional medicines, probiotics, food supplements such as vitamins, minerals, amino acids, essential fatty acids, and protein supplements used in sports) within 14 days prior to dosing or 5 half-lives, whichever is longer, except for the occasional use of paracetamol (up to 2 g daily); * any prescription or over-the-counter medication or natural health products used for the treatment of irregular bowel transit (e.g,. diarrhea, constipation) within 4 weeks prior to dosing; * depot injection or implant of any drug within 3 months prior to dosing; * use of any drugs known to induce or inhibit hepatic metabolism (including St. John's Wort \[hypericin\]) within 14 days prior to dosing. 13. The subject has participated in another investigational study involving any investigational product within 60 days, or 5 half-lives, whichever is longer, before the dose of the study drug. 14. Pregnant or lactating women or women currently undergoing infertility treatments or women who intend to become pregnant during the time of study enrollment. 15. Involvement in the planning and conduct of the study (applies to CRO staff or staff at the study site).

Inclusion Criteria

Exclusion Criteria

1. Subject has signed an Informed Consent Form (ICF) prior to any study-specific procedures being performed
2. Healthy volunteers (HV) with no known acute or chronic medical conditions (respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, endocrine, etc.) at the time of enrollment.
3. Healthy volunteers (HV) with dermatological conditions are allowed if they are not receiving systemic treatments for their dermatological condition.
4. All male and non-pregnant females aged 18-55 years old irrespective of their race and ethnicity.
5. Body Mass Index (BMI) 18.0-30.0 kg/m2, inclusive at screening.
6. Clinical laboratory evaluations performed at screening, are within acceptable normal reference ranges (Grade 1 abnormalities may be acceptable if deemed necessary by the investigator. Grade 2 or higher would be exclusionary).
7. Subjects who are willing and able to adhere to study protocol requirements including but not limited to scheduled outpatient visits, inpatient hospital stay, laboratory tests, and 12-lead ECG.
8. Contraception - All subjects (male and female) must agree to use any two of the highly effective contraception methods listed below. This criterion must be followed from the time of the first dose of study medication for 6 weeks after the last dose in females and for 90 days after the last dose for males.

1. Any known history of malignancy
2. Any known history of asthma
3. COVID-19:
4. Subject with positive results for HBsAg (hepatitis B surface antigens) and/or HBcAb (Hepatitis B core antibodies) and/or HCV Ab (hepatitis C antibodies), and/or HIV Ab (human immunodeficiency virus antibodies).
5. Blood loss of \>250 mL or donated blood within 56 days or donated plasma within 7 days of screening.
6. Recent vaccination with live attenuated vaccines such as influenza, MMR, Herpes zoster, varicella, yellow fever, Rotavirus vaccine, etc., or inactivated vaccines such as Hepatitis A, Rabies vaccine, etc. in the past 30 days.
7. Abnormal amylase levels (Grade 2 or greater)
8. Clinically significant ECG abnormalities (QTcF \>450 ms for males and QTcF \>470 ms for females).
9. History of or current compulsive abuse of alcohol or positive test for alcohol at screening or Day 0 of Visit 1
10. History of or current use of or positive test at screening or Day 0 of Visit 1 for drugs such as marijuana, cocaine, phencyclidine \[PCP\], crack, opioid derivatives including heroin, and amphetamine derivatives.
11. Consumption of any beverages or food containing alcohol or drugs such as marijuana, cocaine, phencyclidine \[PCP\], crack, opioid derivatives including heroin, and amphetamine derivatives from screening until donating the last sample of the study
12. Use of medications for the timeframes specified below, except for medications exempted by the Investigator on a case-by-case basis because they are judged unlikely to affect the PK profile of the study drug or subject safety (e.g., topical drug products without significant systemic absorption):
* prescription medications within 14 days prior to dosing or 5 half-lives, whichever is longer;
* over-the-counter products and natural health products (including herbal remedies homeopathic and traditional medicines, probiotics, food supplements such as vitamins, minerals, amino acids, essential fatty acids, and protein supplements used in sports) within 14 days prior to dosing or 5 half-lives, whichever is longer, except for the occasional use of paracetamol (up to 2 g daily);
* any prescription or over-the-counter medication or natural health products used for the treatment of irregular bowel transit (e.g,. diarrhea, constipation) within 4 weeks prior to dosing;
* depot injection or implant of any drug within 3 months prior to dosing;
* use of any drugs known to induce or inhibit hepatic metabolism (including St. John's Wort \[hypericin\]) within 14 days prior to dosing.
13. The subject has participated in another investigational study involving any investigational product within 60 days, or 5 half-lives, whichever is longer, before the dose of the study drug.
14. Pregnant or lactating women or women currently undergoing infertility treatments or women who intend to become pregnant during the time of study enrollment.
15. Involvement in the planning and conduct of the study (applies to CRO staff or staff at the study site).

Contacts and Locations

Principal Investigator

Mustafa Mahmoud Shennak, MD

PRINCIPAL_INVESTIGATOR

Triumpharma

John Mickelson, DO

PRINCIPAL_INVESTIGATOR

AXIS Clinicals, Dilworth, Minnesota USA

Study Locations (Sites)

AXIS Clinicals

Dilworth, Minnesota, 56529

United States

Collaborators and Investigators

Sponsor: LAPIX Therapeutics Inc.

Mustafa Mahmoud Shennak, MD, PRINCIPAL_INVESTIGATOR, Triumpharma
John Mickelson, DO, PRINCIPAL_INVESTIGATOR, AXIS Clinicals, Dilworth, Minnesota USA

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 Date2023-10-30

Study Completion Date2024-11-01

Study Record Updates

Study Start Date2023-10-30

Study Completion Date2024-11-01

Terms related to this study

Additional Relevant MeSH Terms

Autoimmune Diseases
Multiple Sclerosis