Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental |
| |
| Sequence 2 | Experimental |
| |
| Sequence 3 | Experimental |
| |
| Sequence 4 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment A | Drug | 1600 mg GS-9973 (Formulation 1) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Incidence of Adverse Events |
Not provided
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
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Hawkins, MD | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Daytona Beach | Florida | 32117 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Treatment B |
| Drug |
1600 mg GS-9973 (Formulation 1) plus 20 mg omeprazole |
|
| Treatment C | Drug | 1600 mg GS-9973 (Formulation 1) plus 40 mg famotidine |
|
| Treatment D | Drug | 1600 mg GS-9973 (Formulation 2) |
|
| Treatment E | Drug | 1600 mg GS-9973 (Formulation 2) plus 20 mg omeprazole |
|
| Treatment F | Drug | 1600 mg GS-9973 (Formulation 2) plus 40 mg famotidine |
|
| Treatment G | Drug | 1600 mg GS-9973 (Reference formulation) |
|
| Treatment H | Drug | 1600 mg GS-9973 (Formulation 1 or Formulation 2, based on results from Part A) |
|
| Treatment I | Drug | An alternate dose of the chosen formulation from Part A up to 1200 mg administered twice-daily |
|
| Treatment J | Drug | An alternate dose of the chosen formulation from Part A up to 1200 mg administered twice-daily |
|
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 |
| Blood PD parameters for GS-9973 | A secondary outcome measure is the blood pharmacodynamic parameters. | Up to 3 months |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided