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

Phase 1

Completed

• Conditions: Chronic Lymphocytic Leukemia
• Interventions: Drug: Treatment A; Drug: Treatment D; Drug: Treatment B; Drug: Treatment C; Drug: Treatment E; Drug: Treatment F; Drug: Treatment G; Drug: Treatment H; Drug: Treatment I; Drug: Treatment J

• Registration Number: NCT01841489
• Lead Sponsor: Gilead Sciences

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-04-24
• Study First Submitted QC: 2013-04-24
• Study First Posted: 2013-04-26
• Study Start: 2013-05
• Primary Completion: 2013-08
• Study Completion: 2013-10
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-05
• Last Update Posted: 2014-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 3	Treatment G	-
Sequence 1	Treatment G	-
Sequence 1	Treatment A	-
Sequence 1	Treatment B	-
Sequence 1	Treatment I	-
Sequence 2	Treatment A	-
Sequence 2	Treatment C	-
Sequence 2	Treatment H	-
Sequence 2	Treatment J	-
Sequence 3	Treatment D	-
Sequence 3	Treatment E	-
Sequence 3	Treatment I	-
Sequence 4	Treatment D	-
Sequence 4	Treatment F	-
Sequence 4	Treatment H	-
Sequence 4	Treatment J	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters for GS-9973	Up to 3 months	The primary outcome measure is the pharmacokinetic (PK) parameters for GS-9973 including AUC and Cmax.

Secondary Outcome Measures

Name	Time	Method
Incidence of Adverse Events	Up to 3 months	A secondary outcome measure is the safety and tolerability of GS-9973 which will be evaluated by the incidence of AEs including assessment of clinical laboratory test findings, physical examinations, 12-lead ECG abnormalities, and vital signs measurements.
Secondary pharmacokinetic parameters for GS-9973	Up to 3 months	A secondary outcome measure is the pharmacokinetic parameters for GS-9973 including Ctau and AUClast.
Blood PD parameters for GS-9973	Up to 3 months	A secondary outcome measure is the blood pharmacodynamic parameters.

Trial Locations

Locations (1)

Investigational Site; 🇺🇸 Daytona Beach, Florida, United States