A Phase 1 Study of RO6806127 in Healthy Male Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: Placebo; Drug: RO6806127

• 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

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-16
• Study First Submitted QC: 2014-07-18
• Study First Posted: 2014-07-22
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part 2: Food Effect (FE)	Placebo	Fasted versus Fed
Part 2: Food Effect (FE)	RO6806127	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

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