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

NCT01841489 | Completed Phase 1

• 1 other identifier: GS-US-339-0111
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Lymphocytic Leukemia

Keywords

Chronic Lymphocytic Leukemia; CLL

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Secondary pharmacokinetic parameters for GS-9973

  Up to 3 months

• Incidence of Adverse Events

  Up to 3 months

• Blood PD parameters for GS-9973

  Up to 3 months

Study Arms (4)

Sequence 1

EXPERIMENTAL

Drug: Treatment A; Drug: Treatment B; Drug: Treatment G; Drug: Treatment I

Sequence 2

EXPERIMENTAL

Drug: Treatment A; Drug: Treatment C; Drug: Treatment H; Drug: Treatment J

Sequence 3

EXPERIMENTAL

Drug: Treatment D; Drug: Treatment E; Drug: Treatment G; Drug: Treatment I

Sequence 4

EXPERIMENTAL

Drug: Treatment D; Drug: Treatment F; Drug: Treatment H; Drug: Treatment J

Interventions

Treatment A DRUG

1600 mg GS-9973 (Formulation 1)

Sequence 1; Sequence 2

Treatment B DRUG

1600 mg GS-9973 (Formulation 1) plus 20 mg omeprazole

Sequence 1

Treatment C DRUG

1600 mg GS-9973 (Formulation 1) plus 40 mg famotidine

Sequence 2

Treatment D DRUG

1600 mg GS-9973 (Formulation 2)

Sequence 3; Sequence 4

Treatment E DRUG

1600 mg GS-9973 (Formulation 2) plus 20 mg omeprazole

Sequence 3

Treatment F DRUG

1600 mg GS-9973 (Formulation 2) plus 40 mg famotidine

Sequence 4

Treatment G DRUG

1600 mg GS-9973 (Reference formulation)

Sequence 1; Sequence 3

Treatment H DRUG

1600 mg GS-9973 (Formulation 1 or Formulation 2, based on results from Part A)

Sequence 2; Sequence 4

Treatment I DRUG

An alternate dose of the chosen formulation from Part A up to 1200 mg administered twice-daily

Sequence 1; Sequence 3

Treatment J DRUG

An alternate dose of the chosen formulation from Part A up to 1200 mg administered twice-daily

Sequence 2; Sequence 4

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (1)

Investigational Site

Daytona Beach, Florida, 32117, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Hawkins, MD

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2013
• First Posted: April 26, 2013
• Study Start: May 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: October 1, 2013
• Last Updated: February 7, 2014

Record last verified: 2014-02

Locations

US (1)