Chronic Lymphocytic Leukemia
Conditions
Keywords
Chronic Lymphocytic Leukemia, CLL
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.
Interventions
DRUGTreatment A
1600 mg GS-9973 (Formulation 1)
DRUGTreatment B
1600 mg GS-9973 (Formulation 1) plus 20 mg omeprazole
DRUGTreatment C
1600 mg GS-9973 (Formulation 1) plus 40 mg famotidine
DRUGTreatment D
1600 mg GS-9973 (Formulation 2)
DRUGTreatment E
1600 mg GS-9973 (Formulation 2) plus 20 mg omeprazole
DRUGTreatment F
1600 mg GS-9973 (Formulation 2) plus 40 mg famotidine
DRUGTreatment G
1600 mg GS-9973 (Reference formulation)
DRUGTreatment H
1600 mg GS-9973 (Formulation 1 or Formulation 2, based on results from Part A)
DRUGTreatment I
An alternate dose of the chosen formulation from Part A up to 1200 mg administered twice-daily
DRUGTreatment J
An alternate dose of the chosen formulation from Part A up to 1200 mg administered twice-daily
Sponsors
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Blood PD parameters for GS-9973 | Up to 3 months | A secondary outcome measure is the blood pharmacodynamic parameters. |
Countries
United States
Outcome results
None listed