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

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01841489
• Other study ID #: GS-US-339-0111
• Status: Completed
• Phase: Phase 1
• First received: April 24, 2013
• Last updated: February 5, 2014
• Start date: May 2013
• Est. completion date: October 2013

Study information

• Verified date: February 2014
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Investigational Site	Daytona Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic parameters for GS-9973	The primary outcome measure is the pharmacokinetic (PK) parameters for GS-9973 including AUC and Cmax.	Up to 3 months	No
Secondary	Secondary pharmacokinetic parameters for GS-9973	A secondary outcome measure is the pharmacokinetic parameters for GS-9973 including Ctau and AUClast.	Up to 3 months	No
Secondary	Incidence of Adverse Events	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.	Up to 3 months	Yes
Secondary	Blood PD parameters for GS-9973	A secondary outcome measure is the blood pharmacodynamic parameters.	Up to 3 months	No