A Phase 1 Study of RO6806127 in Healthy Male Volunteers

Healthy Volunteer Clinical Trial

Official title:

A Single-center, Randomised, Double-blind, Adaptative, Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including the Effect of Food), and Pharmacodynamics or RO6806127 in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02196636
• Other study ID #: BP29276
• Secondary ID: 2014-001019-38
• Status: Completed
• Phase: Phase 1
• First received: July 16, 2014
• Last updated: November 1, 2016
• Start date: July 2014
• Est. completion date: January 2015

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• Placebo
Matching placebo, administered orally with approximately 240 mL of buffer
• RO6806127
Administered orally with approximately 240 mL of buffer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		Up to Day 21	No
Secondary	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	No
Secondary	RO6806127 metabolite concentrations in selected plasma and urine samples		Up to Day 21	No
Secondary	Relative bioavailability (food effect): Area under the concentration-time curves [AUC]		Up to Day 21	No