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

Completed · Phase 1

Conditions studied: Chronic Lymphocytic Leukemia

In brief

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.

Key facts

Study ID

NCT01841489

Run by

Gilead Sciences

People needed

56

Starts

2013-05-01

Expected to finish

2013-10-01

Last updated by the study team

2014-02-07

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Investigational Site — Daytona Beach, Florida, United States

Full record on ClinicalTrials.gov

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