A Study to Assess the Relative Bioavailability And Food Effect of a Tablet Formulation of GDC-0276 in Healthy Participants
- Healthy Volunteers
- United Kingdom
NCT02856152 2016-001572-30 GX29841
The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.
The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
This open-label, randomized, 4-way crossover study in healthy participants will determine the relative bioavailability of the tablet formulation relative to the capsule formulation and the effect of a high-fat and low-fat meal on the relative bioavailability of the tablet formulation.
A Single-dose, Open-label, Randomized, 4-way Crossover Study to Assess the Relative Bioavailability And Food Effect of a Tablet Formulation of GDC-0276 in Healthy Subjects
- Body mass index within the range 18.0 to 32.0 kilograms per meter squared (kg/m^2), inclusive, and a minimum weight of 50.0 kg
- Male participants of reproductive potential must be and willing to continue using medically acceptable contraception and must avoid sperm donation from screening and for at least 90 days after the last study drug administration
- Self-reported substance or alcohol dependence (excluding nicotine and caffeine) within the past 2 years, and/or participants who have ever been in a substance or alcohol rehabilitation program to treat their substance or alcohol dependence
- Have used any prescription or over-the-counter (OTC) medication or supplement within 14 days or 5 times the elimination half-life (whichever is longer) before Day -1 until the end of their participation in the study
- Have used any vaccine within 7 days before GDC-0276 administration
- Female participants with a positive serum or urine pregnancy test or are breast feeding
- Donation or loss of more than 500 milliliter (mL) whole blood within 3 months preceding entry into the treatment period
- Blood transfusion within 30 days preceding entry into the treatment period
For the latest version of this information please go to www.forpatients.roche.com