A Phase 1 Study of RO6806127 in Healthy Male Volunteers
- Registration Number
- NCT02196636
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This two-part study will assess the safety and tolerability of single ascending oral doses of RO6806127 in a group of healthy male participants and investigate the effect of high fat and high caloric food on the relative bioavailability of a single oral dose of RO6806127 in a separate group of healthy male participants. The relationship between drug exposure and tolerability will be explored.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 37
Inclusion Criteria
- Healthy male participants aged 18 to 45 years, inclusive
- A BMI between 18 to 30 kg/m2, inclusive
- Agreement to use highly effective contraception
Exclusion Criteria
- Clinically significant abnormalities in laboratory test results
- History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer or cirrhosis
- Significant disorders of the central nervous system, including psychiatric disorders, behavioral disturbances, cerebrovascular events, depression, bipolar disorder, migraine, Parkinson, anxiety, any personal or familial history of seizures, epilepsy or other convulsive condition, previous significant head trauma, or other factors predisposing to seizures
- Use of any prohibited medications and food before study start and during the study
- Dietary restrictions that would prohibit the consumption of standardized meals
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 2: Food Effect (FE) Placebo Fasted versus Fed Part 1: Single Ascending Dose (SAD) Placebo Adaptive model per protocol Part 1: Single Ascending Dose (SAD) RO6806127 Adaptive model per protocol Part 2: Food Effect (FE) RO6806127 Fasted versus Fed
- Primary Outcome Measures
Name Time Method Incidence of adverse events Up to Day 21
- Secondary Outcome Measures
Name Time Method RO6806127 metabolite concentrations in selected plasma and urine samples Up to Day 21 Phamacokinetic profile of single-dose oral RO6806127 and its metabolites as appropriate, as assessed by concentrations over time in plasma and urine Up to Day 21 Relative bioavailability (food effect): Area under the concentration-time curves [AUC] Up to Day 21
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular targets of RO6806127 in phase 1 clinical trials for healthy volunteers?
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What biomarkers are associated with drug response or adverse events in RO6806127 trials involving healthy subjects?
What adverse event profiles have been observed in phase 1 trials of RO6806127, and how are they managed in healthy volunteers?
What is the current status of Hoffmann-La Roche's research on RO6806127, and are there any related compounds or combination therapies being explored for its application in healthy volunteers?