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TDF

Phase 1

Hepatitis B, Chronic | Small molecule | Infectious Disease |GSK plc|Last Updated: Jun 14, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

Clinical trial landscape

TDF · 1 trial · 1 indication

Phase 1 1
NCT01480622Pharmacokinetic (PK) Profiles of Tenofovir Disoproxil Fumarate (TDF) 300 mg in Healthy Chinese SubjectsHepatitis B, Chronic
COMPLETED14 Analytics
PHASE1COMPLETED
Pharmacokinetic (PK) Profiles of Tenofovir Disoproxil Fumarate (TDF) 300 mg in Healthy Chinese Subjects
Hepatitis B, ChronicUnlock trial analytics

Study Endpoints

Primary Endpoints

area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration (AUC(0-t))
up to 60 hours after single dose

AUC(0-t) of single dose

area under the concentration-time curve during steady state (AUC(0-τ))
up to 60 hours after repeat dose

AUC(0-τ) during steady state

Secondary Endpoints

adverse events (AEs)
up to 20 days, from the first dose until the follow-up contact
vital signs
day 1 pre-dose, day 2, day 3, day 10 pre-dose, day 11, day 12 and day 13 prior to discharge from hospital
lab assessment
day 13, prior to discharge from hospital
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TDF tabletsEXPERIMENTALTenofovir disoproxil fumarate tablets

Interventions

NameTypeDescription
TDF tabletsDRUGWhite, almond-shaped, film-coated tablets, one side with the markings "GILEAD" and "4331"
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy, as determined by a responsible and experienced physician * Male or female between 18 and 45 years of age * Body weight \>50 kg (110 lbs) for males or \>45 kg (100 lbs) for females, and body mass index (BMI) between 19.0 and 24.0 kg/m2 Exclusion Criteria: * Positive ...

Countries:China
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Frequently asked questions about TDF

What is TDF used for in Hepatitis B?

TDF is a small molecule being developed for the treatment of chronic Hepatitis B. It is currently in Phase 1 clinical development, meaning it is investigational and has not yet been approved for this indication.

Who makes TDF?

TDF is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The drug is in Phase 1 clinical development for chronic Hepatitis B.

What phase is TDF in?

TDF is in Phase 1 clinical development. It has completed one Phase 1 trial, and no active trials are currently listed. The drug remains investigational and has not been approved for any use.

What clinical trials is TDF in?

TDF has one completed clinical trial, NCT01480622, titled 'Pharmacokinetic (PK) Profiles of Tenofovir Disoproxil Fumarate (TDF) 300 mg in Healthy Chinese Subjects.' This Phase 1 study enrolled 14 participants and was conducted in China.

Is TDF the same as Tenofovir Disoproxil Fumarate?

Yes, TDF is an abbreviation for Tenofovir Disoproxil Fumarate. The completed clinical trial NCT01480622 explicitly studies TDF 300 mg, confirming that TDF and Tenofovir Disoproxil Fumarate refer to the same drug.