Evaluation of Pharmacokinetic Interaction Between GSK3640254 and Caffeine, Metoprolol, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin in Healthy Adults

NCT04425902 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 213052
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, single sequence study that is being conducted to investigate the potential drug-drug interaction (DDI) when GSK3640254 is co-administered with a cocktail of cytochrome P450 (CYP) enzymes and transporter probe substrates in healthy participants. This study will aid in understanding these interactions and resulting changes in exposure (if any) when drugs that are metabolized via these pathways are given in combination with GSK3640254. The study will consist of a Screening period and 3 sequential treatment regimens. Participants will be administered a single dose of probe substrate drugs (caffeine 200 milligram (mg), metoprolol 100 mg, montelukast 10 mg, flurbiprofen 100 mg, omeprazole 40 mg, midazolam 5 mg, digoxin 0.25 mg and pravastatin 40 mg) on Day 1. Participants will then receive GSK3640254 200 mg once daily on Days 11 to 20 followed by co-administration of probe substrate drugs with GSK3640254 on Day 21.

Conditions

HIV Infections

Keywords

GSK3640254; Human immunodeficiency virus (HIV) infections; Drug interaction; Pharmacokinetics; Probe substrate

Outcome Measures

Primary Outcomes (40)

• Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Time t (AUC[0-t]) for Caffeine

  Blood samples were collected at the indicated time points for pharmacokinetic analysis of caffeine. Area under the plasma concentration-time curve from time zero to time t, to be calculated using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid.

  Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

• AUC From Time Zero Extrapolated to Infinity (AUC[0-infinity]) for Caffeine

  Blood samples were collected at the indicated time points for pharmacokinetic analysis of caffeine. The AUC(0-infinity) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid.

  Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

• Maximum Observed Plasma Concentration (Cmax) for Caffeine

  Blood samples were collected at the indicated time points for pharmacokinetic analysis of caffeine.

  Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

• Time to Cmax (Tmax) for Caffeine

  Blood samples were collected at the indicated time points for pharmacokinetic analysis of caffeine.

  Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

• Apparent Terminal Phase Half-life (t1/2) for Caffeine

  Blood samples were collected at the indicated time points for pharmacokinetic analysis of caffeine.

  Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

• AUC(0-t) for Metoprolol

  Blood samples were collected at the indicated time points for pharmacokinetic analysis of metoprolol. The AUC(0-t) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid.

  Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

• AUC(0-infinity) for Metoprolol

  Blood samples were collected at the indicated time points for pharmacokinetic analysis of metoprolol. The AUC(0-infinity) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid.

  Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

• Cmax for Metoprolol

  Blood samples were collected at the indicated time points for pharmacokinetic analysis of metoprolol.

  Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

• Tmax for Metoprolol

  Blood samples were collected at the indicated time points for pharmacokinetic analysis of metoprolol.

  Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

• t1/2 for Metoprolol

  Blood samples were collected at the indicated time points for pharmacokinetic analysis of metoprolol.

  Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

• AUC(0-t) for Montelukast

  Blood samples were collected at the indicated time points for pharmacokinetic analysis of montelukast. The AUC(0-t) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid.

  Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

• AUC(0-infinity) for Montelukast

  Blood samples were collected at the indicated time points for pharmacokinetic analysis of montelukast. The AUC(0-infinity) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid.

  Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

• Cmax for Montelukast

  Blood samples were collected at the indicated time points for pharmacokinetic analysis of montelukast.

  Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

• Tmax for Montelukast

  Blood samples were collected at the indicated time points for pharmacokinetic analysis of montelukast.

  Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

• t1/2 for Montelukast

  Blood samples were collected at the indicated time points for pharmacokinetic analysis of montelukast.

  Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

• AUC(0-t) for Flurbiprofen

  Blood samples were collected at the indicated time points for pharmacokinetic analysis of flurbiprofen. The AUC(0-t) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid.

  Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

• AUC(0-infinity) for Flurbiprofen

  Blood samples were collected at the indicated time points for pharmacokinetic analysis of flurbiprofen. The AUC(0-infinity) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid.

  Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

• Cmax for Flurbiprofen

  Blood samples were collected at the indicated time points for pharmacokinetic analysis of flurbiprofen.

  Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

• Tmax for Flurbiprofen

  Blood samples were collected at the indicated time points for pharmacokinetic analysis of flurbiprofen.

  Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

• t1/2 for Flurbiprofen

  Blood samples were collected at the indicated time points for pharmacokinetic analysis of flurbiprofen.

  Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

• AUC(0-t) for Omeprazole

  Blood samples were collected at the indicated time points for pharmacokinetic analysis of omeprazole. The AUC(0-t) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid.

  Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

• AUC(0-infinity) for Omeprazole

  Blood samples were collected at the indicated time points for pharmacokinetic analysis of omeprazole. The AUC(0-infinity) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid.

  Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

• Cmax for Omeprazole

  Blood samples were collected at the indicated time points for pharmacokinetic analysis of omeprazole.

  Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

• Tmax for Omeprazole

  Blood samples were collected at the indicated time points for pharmacokinetic analysis of omeprazole.

  Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

• t1/2 for Omeprazole

  Blood samples were collected at the indicated time points for pharmacokinetic analysis of omeprazole.

  Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

• AUC(0-t) for Midazolam

  Blood samples were collected at the indicated time points for pharmacokinetic analysis of midazolam. The AUC(0-t) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid.

  Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

• AUC(0-infinity) for Midazolam

  Blood samples were collected at the indicated time points for pharmacokinetic analysis of midazolam. The AUC(0-infinity) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid.

  Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

• Cmax for Midazolam

  Blood samples were collected at the indicated time points for pharmacokinetic analysis of midazolam.

  Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

• Tmax for Midazolam

  Blood samples were collected at the indicated time points for pharmacokinetic analysis of midazolam.

  Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

• t1/2 for Midazolam

  Blood samples were collected at the indicated time points for pharmacokinetic analysis of midazolam.

  Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

• AUC(0-t) for Digoxin

  Blood samples were collected at the indicated time points for pharmacokinetic analysis of digoxin. The AUC(0-t) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid.

  Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

• AUC(0-infinity) for Digoxin

  Blood samples were collected at the indicated time points for pharmacokinetic analysis of digoxin. The AUC(0-infinity) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid.

  Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

• Cmax for Digoxin

  Blood samples were collected at the indicated time points for pharmacokinetic analysis of digoxin.

  Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

• Tmax for Digoxin

  Blood samples were collected at the indicated time points for pharmacokinetic analysis of digoxin.

  Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

• t1/2 for Digoxin

  Blood samples were collected at the indicated time points for pharmacokinetic analysis of digoxin.

  Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

• AUC(0-t) for Pravastatin

  Blood samples were collected at the indicated time points for pharmacokinetic analysis of pravastatin. The AUC(0-t) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid.

  Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

• AUC(0-infinity) for Pravastatin

  Blood samples were collected at the indicated time points for pharmacokinetic analysis of pravastatin. The AUC(0-infinity) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid.

  Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

• Cmax for Pravastatin

  Blood samples were collected at the indicated time points for pharmacokinetic analysis of pravastatin.

  Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

• Tmax for Pravastatin

  Blood samples were collected at the indicated time points for pharmacokinetic analysis of pravastatin.

  Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

• t1/2 for Pravastatin

  Blood samples were collected at the indicated time points for pharmacokinetic analysis of pravastatin.

  Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

Secondary Outcomes (131)

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Up to Day 26

• Treatment A: Absolute Values of Platelet Count, Leukocyte Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils

  Baseline (Day -1) and Day 10

• Treatment B: Absolute Values of Platelet Count, Leukocyte Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils

  Baseline (Day 10) and Day 20

• Treatment C: Absolute Values of Platelet Count, Leukocyte Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils

  Baseline (Day 20), Days 22 and 25

• Treatment A: Absolute Values of Hematocrit

  Baseline (Day -1) and Day 10

Study Arms (1)

Probe Substrates/GSK3640254 200 mg/Probe Substrates+GSK3640254

EXPERIMENTAL

All participants will receive a single dose of treatment A: Probe substrates (caffeine 200 milligram \[mg\], metoprolol 100 mg, montelukast 10 mg, flurbiprofen 100 mg, omeprazole 40 mg, midazolam 5 mg, digoxin 0.25 mg, and pravastatin 40 mg) on Day 1; followed by treatment B- GSK3640254 200 mg on Days 11 to 20; further followed by treatment C: Probe substrates (Caffeine 200 mg, metoprolol 100 mg, montelukast 10 mg, flurbiprofen 100 mg, omeprazole 40 mg, midazolam 5 mg, digoxin 0.25 mg, and pravastatin 40 mg) co-administered with GSK3640254 200 mg on Day 21.

Drug: GSK3640254 200 mg; Drug: Caffeine 200 mg; Drug: Metoprolol 100 mg; Drug: Montelukast 10 mg; Drug: Flurbiprofen 100 mg; Drug: Omeprazole 40 mg; Drug: Midazolam 5 mg (2.5 mL); Drug: Digoxin 0.25 mg; Drug: Pravastatin 40 mg

Interventions

GSK3640254 200 mg DRUG

GSK3640254 will be available as oral tablets at unit dose strength of 100 mg.

Probe Substrates/GSK3640254 200 mg/Probe Substrates+GSK3640254

Caffeine 200 mg DRUG

Caffeine will be available as oral tablets at unit dose strength of 200 mg.

Probe Substrates/GSK3640254 200 mg/Probe Substrates+GSK3640254

Metoprolol 100 mg DRUG

Metoprolol will be available as oral tablets at unit dose strength of 100 mg.

Probe Substrates/GSK3640254 200 mg/Probe Substrates+GSK3640254

Montelukast 10 mg DRUG

Montelukast will be available as oral tablets at unit dose strength of 10 mg.

Probe Substrates/GSK3640254 200 mg/Probe Substrates+GSK3640254

Flurbiprofen 100 mg DRUG

Flurbiprofen will be available as oral tablets at unit dose strength of 100 mg.

Probe Substrates/GSK3640254 200 mg/Probe Substrates+GSK3640254

Omeprazole 40 mg DRUG

Omeprazole will be available as oral capsules at unit dose strength of 40 mg.

Probe Substrates/GSK3640254 200 mg/Probe Substrates+GSK3640254

Midazolam 5 mg (2.5 mL) DRUG

Midazolam will be available as syrup for oral administration at unit dose strength of 2 milligram per milliliter (mg/mL).

Probe Substrates/GSK3640254 200 mg/Probe Substrates+GSK3640254

Digoxin 0.25 mg DRUG

Digoxin will be available as oral tablet at unit dose strength of 0.25 mg.

Probe Substrates/GSK3640254 200 mg/Probe Substrates+GSK3640254

Pravastatin 40 mg DRUG

Pravastatin will be available as oral tablet at unit dose strength of 40 mg.

Probe Substrates/GSK3640254 200 mg/Probe Substrates+GSK3640254

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participant must be 18 to 50 years of age inclusive, at the time of signing the informed consent.
• Participants who are overtly healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination (including cardiopulmonary examination), laboratory tests, and cardiac monitoring (history and ECG).
• Body weight more than or equal to (\>=) 50.0 kilograms (kg) (110 pounds \[lbs\]) for men and \>=45.0 kg (99 lbs) for women and body mass index within the range 18.5 to 31.0 kilogram per square meter (kg/m\^2) (inclusive).
• Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Male participants should not engage in intercourse while confined in the clinic. There is no need for an extended period of double barrier use or prolonged abstinence after study discharge.
• A female participant is eligible to participate if she is not pregnant or breastfeeding and at least one of the following conditions applies:
• Is not a woman of childbearing potential (WOCBP) or
• Is a WOCBP and using a non-hormonal contraceptive method that is highly effective, with a failure rate of less than (\<) 1 percent (%) for 28 days before intervention, during the intervention period, and for at least 28 days after the last dose of study intervention.
• A WOCBP must have a negative highly sensitive serum pregnancy test at Screening and check-in (Day-1).
• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions, listed in the informed consent form (ICF) and in the protocol.

You may not qualify if:

• Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
• A pre-existing condition interfering with normal gastrointestinal (GI) anatomy or motility (e.g., gastro-esophageal reflux disease, gastric ulcers, gastritis) or hepatic and/or renal function that could interfere with the absorption, metabolism, and/or excretion of the study intervention or render the participant unable to take oral study intervention.
• Prior cholecystectomy surgery.
• Any history of significant underlying psychiatric disorder, including, but not limited to, schizophrenia, bipolar disorder with or without psychotic symptoms, other psychotic disorders, or schizotypal (personality) disorder.
• Any history of major depressive disorder with or without suicidal features, or anxiety disorders that required medical intervention (pharmacologic or not) such as hospitalization or other inpatient treatment and/or chronic (\>6 months) outpatient treatment.
• Participants with other conditions such as adjustment disorder or dysthymia that have required shorter term medical therapy (\<6 months) without inpatient treatment and are currently well-controlled clinically or resolved may be considered for entry after discussion and agreement with the ViiV Healthcare (VH)/GlaxoSmithKline (GSK) Medical Monitor.
• Any pre-existing physical or other psychiatric condition (including alcohol or drug abuse), which, in the opinion of the investigator (with or without psychiatric evaluation), could interfere with the participant's ability to comply with the dosing schedule and protocol evaluations or which might compromise the safety of the participant.
• Medical history of cardiac arrhythmias, prior myocardial infarction in the past 3 months, or cardiac disease or a family or personal history of long QT syndrome.
• History of asthma, bronchospasm, or sleep apnea.
• History of chronic musculoskeletal pain (myalgias).
• History of rhabdomyolysis.
• History of a bleeding disorder.
• History of Raynaud's disease.
• History indicative of an increased risk of a cardiac arrhythmia or cardiac disease, including the following:
• History of cardiac arrhythmias or palpitations associated with presyncope or syncope, or history of unexplained syncope.

Sponsors & Collaborators

• ViiV Healthcare: lead

Study Sites (1)

GSK Investigational Site

Las Vegas, Nevada, 89113, United States

Location

Related Publications (1)

• Zhang Y, Johnson M, Joshi S, Yazdani P, Zhan J, Wen B, Bainbridge V, Gartland M, Lataillade M. Open-label, drug-drug interaction study between the HIV-1 maturation inhibitor GSK3640254 and a metabolic probe cocktail in healthy participants. Br J Clin Pharmacol. 2023 Jul;89(7):2236-2245. doi: 10.1111/bcp.15699. Epub 2023 Mar 13.

  PMID: 36822839 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; Infections

Interventions

GSK3640254; Caffeine; Metoprolol; montelukast; Flurbiprofen; Omeprazole; Midazolam; Digoxin; Pravastatin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Propionates; Acids, Acyclic; Carboxylic Acids; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles; Benzodiazepines; Benzazepines; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates; Naphthalenes; Polycyclic Aromatic Hydrocarbons

Results Point of Contact

• Title: GSK Response Center
• Organization: ViiV Healthcare

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  ViiV Healthcare

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: This is a single-group, single-arm study that has no masking.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a single-sequence, one-way drug interaction study.

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 11, 2020
• Study Start: December 16, 2020
• Primary Completion: March 10, 2021
• Study Completion: March 10, 2021
• Last Updated: January 5, 2024
• Results First Posted: May 23, 2022

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

US (1)