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 range18 Years – 55 Years

SexALL

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.
✕. Unstable liver disease known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per Investigator assessment).

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

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

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 range18 Years – 55 Years

SexALL

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.
✕. Unstable liver disease known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per Investigator assessment).

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

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