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

Gilead Sciences

Status and phase: Completed; Phase 1

Conditions: Chronic Lymphocytic Leukemia

Treatments: Drug: Treatment B; Drug: Treatment I; Drug: Treatment A; Drug: Treatment H; Drug: Treatment C; Drug: Treatment J; Drug: Treatment D; Drug: Treatment F; Drug: Treatment E; Drug: Treatment G

Study type: Interventional

Funder types: Industry

Identifiers

NCT01841489

GS-US-339-0111

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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56 participants in 4 patient groups

Sequence 1

Experimental group

Treatment:

Drug: Treatment G

Drug: Treatment I

Drug: Treatment A

Drug: Treatment B

Sequence 2

Experimental group

Treatment:

Drug: Treatment C

Drug: Treatment J

Drug: Treatment A

Drug: Treatment H

Sequence 3

Experimental group

Treatment:

Drug: Treatment G

Drug: Treatment I

Drug: Treatment D

Drug: Treatment E

Sequence 4

Experimental group

Treatment:

Drug: Treatment J

Drug: Treatment F

Drug: Treatment H

Drug: Treatment D