Clinical trial · Interventional
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
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
NCT01841489CI-TRIAL-00013703completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Treatment A | Drug | — | UNRESOLVED |
| Treatment B | Drug | — | UNRESOLVED |
| Treatment C | Drug | — | UNRESOLVED |
| Treatment D | Drug | — | UNRESOLVED |
| Treatment E | Drug | — | UNRESOLVED |
| Treatment F | Drug | — | UNRESOLVED |
| Treatment G | Drug | — | UNRESOLVED |
| Treatment H | Drug | — | UNRESOLVED |
| Treatment I | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Sequence 1
- interventionNames
- Drug: Treatment A
- Drug: Treatment B
- Drug: Treatment G
- Drug: Treatment I
- type
- EXPERIMENTAL
- label
- Sequence 2
- interventionNames
- Drug: Treatment A
- Drug: Treatment C
- Drug: Treatment H
- Drug: Treatment J
- type
- EXPERIMENTAL
- label
- Sequence 3
- interventionNames
- Drug: Treatment D
- Drug: Treatment E
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.