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Tenofovir alafenamide/emtricitabine

Phase 1

HIV Infections | Small molecule | Infectious Disease |GSK plc|Last Updated: Apr 21, 2020

Target and mechanism

ModalitySmall molecule

Also known as Tenofovir alafenamide

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

Tenofovir alafenamide/emtricitabine · 1 trial · 1 indication

Phase 1 1
NCT03836729Study to Evaluate the Effect of GSK3640254 on the Pharmacokinetics of Tenofovir Alafenamide/EmtricitabineHIV Infections
COMPLETED16 Analytics
PHASE1COMPLETED
Study to Evaluate the Effect of GSK3640254 on the Pharmacokinetics of Tenofovir Alafenamide/Emtricitabine
HIV InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

Period 1: Area Under the Plasma Concentration-time Curve From Time 0 to the End of the Dosing Interval at Steady State (AUC [0-tau]) of TAF
Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

Blood samples were collected at indicated time-points for analysis of AUC (0-tau). Pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis. PK Parameter Population included all participants who underwent plasma PK sampling and had evaluable PK parameters estimated.

Period 2: AUC (0-tau) of TAF
Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.

Period 1: Maximum Observed Concentration (Cmax) of TAF
Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.

Period 2: Cmax of TAF
Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.

Period 1: AUC (0-tau) of FTC
Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.

Period 2: AUC (0-tau) of FTC
Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.

Period 1:Cmax of FTC
Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.

Period 2:Cmax of FTC
Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.

Period 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of FTC
Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis.

Period 2: Ctau of FTC
Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis.

Period 1: AUC (0-tau) of Tenofovir (TFV)
Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.

Period 2: AUC (0-tau) of TFV
Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.

Period 1: Cmax of TFV
Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.

Period 2: Cmax of TFV
Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.

Period 1: Ctau of TFV
Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis.

Period 2: Ctau of TFV
Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis.

Secondary Endpoints

Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAE)
Up to Day 24
Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Baseline and at Days 7, and 14
Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Baseline and at Days 3, 7, 9
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Study Design & Arms

MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TAF/FTC followed by TAF/FTC + GSK3640254EXPERIMENTALSubjects will receive TAF/FTC 25/200 mg QD on Days 1 through 14 in Treatment Period 1. Subjects will be co-administered TAF/FTC 25/200 mg QD with GSK3640254 200 mg QD on Days 1 through 7 in Treatment Period 2.

Interventions

NameTypeDescription
Tenofovir alafenamide/emtricitabineDRUGTAF/FTC will be available as 25/200 milligrams (mg) tablet. Subjects will be administered TAF/FTC 25/200 mg QD via the oral route.
GSK3640254DRUGGSK3640254 will be available as 100 mg capsule. Subjects will be administered GSK3640254 200 mg capsule QD via the oral route.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subject must be 18 to 55 years of age inclusive, at the time of signing the informed consent. * Subjects who are healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory ...

Countries:United States
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Frequently asked questions about Tenofovir alafenamide/emtricitabine

What is Tenofovir alafenamide/emtricitabine used for in HIV Infections?

Tenofovir alafenamide/emtricitabine is a small molecule being studied for use in HIV Infections. It is currently in Phase 1 clinical development as an investigational drug. The combination is being evaluated for its potential role in treating HIV, though it is not yet approved for this indication.

Who makes Tenofovir alafenamide/emtricitabine?

Tenofovir alafenamide/emtricitabine is being developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical research on this drug combination for the treatment of HIV Infections.

What phase is Tenofovir alafenamide/emtricitabine in?

Tenofovir alafenamide/emtricitabine is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, with no active trials currently ongoing.

What clinical trials is Tenofovir alafenamide/emtricitabine in?

Tenofovir alafenamide/emtricitabine has been studied in one completed clinical trial, NCT03836729, titled 'Study to Evaluate the Effect of GSK3640254 on the Pharmacokinetics of Tenofovir Alafenamide/Emtricitabine'. This Phase 1 trial enrolled 16 participants in the United States and involved healthy volunteers.

Is Tenofovir alafenamide/emtricitabine the same as Tenofovir alafenamide?

Tenofovir alafenamide/emtricitabine is also known as Tenofovir alafenamide. The drug is a combination product that includes tenofovir alafenamide as one of its components, along with emtricitabine. In clinical development, it is referred to by either name.