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A Phase 1 Study of RO6806127 in Healthy Male Volunteers

NCT02196636 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2016-11-02

No results posted yet for this study

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.

Conditions

  • Healthy Volunteer

Interventions

DRUG

Placebo

Matching placebo, administered orally with approximately 240 mL of buffer

DRUG

RO6806127

Administered orally with approximately 240 mL of buffer

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02196636 on ClinicalTrials.gov