A Phase 1 Study of Novel GS-9973 Tablet Formulations to Evaluate the Effect of Acid Reducing Agents, Relative Bioavailability, and Food Effect on GS-9973 Pharmacokinetics

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gilead Sciences

Criteria

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