WithdrawnPhase 1

VH3739937 Phase 1 Multiple Ascending Dose (MAD) Study in Healthy Volunteers Including Relative Bioavailability (RBA), Optional Food Effect (FE), and Drug-drug Interaction (DDI)

Stopped: Sponsor decision

United States0Started 2024-08-02

Plain-language summary

This study will assess safety, tolerability and pharmacokinetic (PK) of VH3739937 in healthy participants.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Participants who are overtly healthy as determined by the Investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (history and ECG).
. Participants who can understand and comply with protocol requirements and timetables, instructions, and protocol-stated restrictions.
. Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
. Body weight \>=50.0 kg (110 lbs) for men and \>=45.0 kg (99 lbs) for women, and BMI within the range 18.5 to 32.0 kg/m2 (inclusive).
. Participants male at birth and participants female at birth:
. Participants male at birth:
. Participants female at birth:
. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.

Exclusion criteria

. History or presence of cardiovascular, respiratory, hepatic, renal, GI, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part A: Number of participants with any adverse events (AEs)

Timeframe: Up to Day 25 for Cohorts A1 and A2 and Day 30 for Cohort A3

Part B: Number of participants with any adverse events (AEs)

Timeframe: Up to Day 15

Part C: Number of participants with any adverse events (AEs)

Timeframe: Up to Day 42

Part D: Number of participants with any adverse events (AEs)

Timeframe: Up to Day 28

Part A: Number of participants with adverse events (AEs) by grade of severity

Timeframe: Up to Day 25 for Cohorts A1 and A2, and Day 30 for Cohort A3

Part B: Number of participants with adverse events (AEs) by grade of severity

Timeframe: Up to Day 15 (Periods 2 and 4 only)

Part C: Number of participants with adverse events (AEs) by grade of severity

Timeframe: Up to Day 42

Trial details

NCT IDNCT06533280

SponsorViiV Healthcare

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-14

View on ClinicalTrials.gov More HIV Infections trials

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Participants who are overtly healthy as determined by the Investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (history and ECG).
. Participants who can understand and comply with protocol requirements and timetables, instructions, and protocol-stated restrictions.
. Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
. Body weight \>=50.0 kg (110 lbs) for men and \>=45.0 kg (99 lbs) for women, and BMI within the range 18.5 to 32.0 kg/m2 (inclusive).
. Participants male at birth and participants female at birth:
. Participants male at birth:
. Participants female at birth:
. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.

Exclusion criteria

. History or presence of cardiovascular, respiratory, hepatic, renal, GI, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.

What they're measuring

Part A: Number of participants with any adverse events (AEs)

Timeframe: Up to Day 25 for Cohorts A1 and A2 and Day 30 for Cohort A3

Part B: Number of participants with any adverse events (AEs)

Timeframe: Up to Day 15

Part C: Number of participants with any adverse events (AEs)

Timeframe: Up to Day 42

Part D: Number of participants with any adverse events (AEs)

Timeframe: Up to Day 28

Part A: Number of participants with adverse events (AEs) by grade of severity

Timeframe: Up to Day 25 for Cohorts A1 and A2, and Day 30 for Cohort A3

Part B: Number of participants with adverse events (AEs) by grade of severity

Timeframe: Up to Day 15 (Periods 2 and 4 only)

Part C: Number of participants with adverse events (AEs) by grade of severity

Timeframe: Up to Day 42