Status:
COMPLETED
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
Lead Sponsor:
Gilead Sciences
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT01841489
Start Date
May 1 2013
End Date
October 1 2013
Last Update
February 7 2014
Active Locations (1)
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1
Investigational Site
Daytona Beach, Florida, United States, 32117