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
NCT ID: NCT01841489
Last Updated: 2014-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
56 participants
INTERVENTIONAL
2013-05-31
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Sequence 1
Treatment A
1600 mg GS-9973 (Formulation 1)
Treatment B
1600 mg GS-9973 (Formulation 1) plus 20 mg omeprazole
Treatment G
1600 mg GS-9973 (Reference formulation)
Treatment I
An alternate dose of the chosen formulation from Part A up to 1200 mg administered twice-daily
Sequence 2
Treatment A
1600 mg GS-9973 (Formulation 1)
Treatment C
1600 mg GS-9973 (Formulation 1) plus 40 mg famotidine
Treatment H
1600 mg GS-9973 (Formulation 1 or Formulation 2, based on results from Part A)
Treatment J
An alternate dose of the chosen formulation from Part A up to 1200 mg administered twice-daily
Sequence 3
Treatment D
1600 mg GS-9973 (Formulation 2)
Treatment E
1600 mg GS-9973 (Formulation 2) plus 20 mg omeprazole
Treatment G
1600 mg GS-9973 (Reference formulation)
Treatment I
An alternate dose of the chosen formulation from Part A up to 1200 mg administered twice-daily
Sequence 4
Treatment D
1600 mg GS-9973 (Formulation 2)
Treatment F
1600 mg GS-9973 (Formulation 2) plus 40 mg famotidine
Treatment H
1600 mg GS-9973 (Formulation 1 or Formulation 2, based on results from Part A)
Treatment J
An alternate dose of the chosen formulation from Part A up to 1200 mg administered twice-daily
Interventions
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Treatment A
1600 mg GS-9973 (Formulation 1)
Treatment B
1600 mg GS-9973 (Formulation 1) plus 20 mg omeprazole
Treatment C
1600 mg GS-9973 (Formulation 1) plus 40 mg famotidine
Treatment D
1600 mg GS-9973 (Formulation 2)
Treatment E
1600 mg GS-9973 (Formulation 2) plus 20 mg omeprazole
Treatment F
1600 mg GS-9973 (Formulation 2) plus 40 mg famotidine
Treatment G
1600 mg GS-9973 (Reference formulation)
Treatment H
1600 mg GS-9973 (Formulation 1 or Formulation 2, based on results from Part A)
Treatment I
An alternate dose of the chosen formulation from Part A up to 1200 mg administered twice-daily
Treatment J
An alternate dose of the chosen formulation from Part A up to 1200 mg administered twice-daily
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
45 Years
ALL
Yes
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Hawkins, MD
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Investigational Site
Daytona Beach, Florida, United States
Countries
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Other Identifiers
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GS-US-339-0111
Identifier Type: -
Identifier Source: org_study_id
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