NCT01841489CompletedPhase 1
A Phase 1, Open-Label, Adaptive Study of Novel GS-9973 Tablet Formulations to Evaluate the Effect of Acid Reducing Agents, Relative Bioavailability, and Food Effect on GS-9973 Pharmacokinetics
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Gilead Sciences
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Pharmacokinetic parameters for GS-9973
Study Overview
Brief Summary
This is a Phase 1, Open-Label, Adaptive Study of Novel GS-9973 Tablet Formulations to Evaluate the Effect of Acid Reducing Agents, Relative Bioavailability, and Food Effect on GS-9973 Pharmacokinetics.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
- •Must have a body mass index (BMI) range of approximately 19 to 30 kg/m2
- •Must have a minimum weight of 45 kg
- •Females of childbearing potential must have negative serum pregnancy tests at screening and baseline and must practice at least 1 reliable method of contraception as defined by the protocol
- •Female subjects who utilize hormonal contraceptive as 1 of their birth control methods must have used the same method for at least 3 months prior to study dosing
- •Male subjects must agree to use condoms during heterosexual intercourse and avoid sperm donation from Day -1 until 90 days following the last dose of study medication
- •Must refrain from blood donation throughout the study period
- •Must, in the opinion of the Investigator, be in good general
- •Must be a non- or light smoker, eg, less than 10 cigarettes per day
Exclusion Criteria
- •Pregnant or lactating subjects
- •Use of prescribed or over-the-counter medications that affect gastric pH
- •History of severe peptic ulcer disease, GERD, or other diseases requiring prolonged(>6 weeks) medication or surgical therapy to modify gastric pH
- •Have a history of clinically significant cardiac abnormalities or presence of clinically significant abnormality on 12-lead ECG.
- •Have a history of any cancer requiring systemic chemotherapy or radiation
- •Have a history of bleeding disorders
- •Have a history of liver disorders
- •Current acute infection or history of acute infection within 7 days
- •Have a recent history of alcohol or illicit drug abuse and/or have a positive test for selected drugs of abuse
- •Have a positive hepatitis screen or positive Human Immunodeficiency Virus antibody test
- •Have participated in another clinical trial within 28 days
- •Have received transfusion of blood or plasma products within 6 months
- •Have donated > 500 mL blood within 56 days
- •Are unable or unwilling to comply with study restrictions, return for follow-up appointments, or other considerations, which in the opinion of the Investigator, would make the candidate unsuitable for study participation
- •Current or historical medical condition that is deemed to be of medical significance by the Investigator
- •Have used prescription medications, over the counter products, herbal remedies and nutritional supplements within 7 days
Arms & Interventions
Sequence 1
Experimental
Intervention: Treatment A (Drug)
Sequence 1
Experimental
Intervention: Treatment B (Drug)
Sequence 1
Experimental
Intervention: Treatment G (Drug)
Sequence 1
Experimental
Intervention: Treatment I (Drug)
Sequence 2
Experimental
Intervention: Treatment A (Drug)
Sequence 2
Experimental
Intervention: Treatment C (Drug)
Sequence 2
Experimental
Intervention: Treatment H (Drug)
Sequence 2
Experimental
Intervention: Treatment J (Drug)
Sequence 3
Experimental
Intervention: Treatment D (Drug)
Sequence 3
Experimental
Intervention: Treatment E (Drug)
Sequence 3
Experimental
Intervention: Treatment G (Drug)
Sequence 3
Experimental
Intervention: Treatment I (Drug)
Sequence 4
Experimental
Intervention: Treatment D (Drug)
Sequence 4
Experimental
Intervention: Treatment F (Drug)
Sequence 4
Experimental
Intervention: Treatment H (Drug)
Sequence 4
Experimental
Intervention: Treatment J (Drug)
Outcomes
Primary Outcomes
Pharmacokinetic parameters for GS-9973
Time Frame: Up to 3 months
The primary outcome measure is the pharmacokinetic (PK) parameters for GS-9973 including AUC and Cmax.
Secondary Outcomes
- Incidence of Adverse Events(Up to 3 months)
- Secondary pharmacokinetic parameters for GS-9973(Up to 3 months)
- Blood PD parameters for GS-9973(Up to 3 months)
Investigators
Study Sites (1)
Loading locations...
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