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TDF

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment14
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01480622Pharmacokinetic (PK) Profiles of Tenofovir Disoproxil Fumarate (TDF) 300 mg in Healthy Chinese SubjectsPHASE1 COMPLETED 14 — — Dec 5, 2011Dec 30, 2011Jun 14, 20171 China
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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 — 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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