Phase 1
Completed N=20
A Study to Evaluate the Effect of a Proton-Pump Inhibitor (Rabeprazole) on the Relative Bioavailability of Cobimetinib in Healthy Participants
Healthy Volunteer
Source: ClinicalTrials.gov NCT01277718 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcomePrimary: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Cobimetinib — 778; 864; 846 nanograms*hours/milliliter (ng*hr/mL)
Summary
This is a Phase 1, single-center, open-label, randomized, 3-period, 2-sequence crossover study of cobimetinib in healthy participants to evaluate the effect of the proton-pump inhibitor (PPI) rabeprazole on the relative bioavailability of cobimetinib in healthy participants when administered in the fed or fasted states.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Cobimetinib |
778; 864; 846 | — |
| PRIMARY Maximum Observed Concentration of Cobimetinib |
17.0; 17.2; 14.8 | — |
Eligibility Criteria
Inclusion Criteria
- With a body mass index range of 18.5 to 29.9 kilograms per meter square (kg/m^2)
- In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), and vital signs
- Clinical laboratory evaluations within the reference range for the test laboratory
- Negative test for selected drugs of abuse at Screening (does not include alcohol) and at each Check-in
- Negative hepatitis panel (including hepatitis B virus surface antigen [HBsAg] and hepatitis C virus antibody [anti-HCV]) and negative human immunodeficiency virus (HIV) antibody screens
- Healthy males and females of nonchildbearing potential who agree to use effective contraception
Exclusion Criteria
- Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs, except that appendectomy, hernia repair, and/or cholecystectomy will be allowed
- History or presence of an abnormal ECG
- History of alcoholism or drug addiction within 1 year prior to Period 1 Check-in
- Use of any tobacco- or nicotine-containing products within 6 months prior to Period 1 Check-in
- Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 30 days or 5 half-lives, whichever is longer, prior to Period 1 Check-in
- Use of any prescription medications/products within 14 days prior to Period 1 Check-in
- Use of any over-the-counter, non-prescription preparations within 7 days prior to Period 1 Check-in
- Use of alcohol-, grapefruit-, or caffeine-containing foods or beverages within 72 hours prior to Period 1 Check-in
- Poor peripheral venous access
- Any acute or chronic condition that would limit the participant's ability to complete and/or participate in this clinical study
- Female participant is pregnant, lactating, or breastfeeding
- Use of PPIs or histamine H2 receptor antagonists within 1 month prior to Period 1 Check-in
- Known hypersensitivity to rabeprazole or any of its components or to derived products of benzimidazoles
- Predisposing factors to retinal vein occlusion (RVO)
Data sourced from ClinicalTrials.gov (NCT01277718). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.