Skip to main content
OpenTrials
Completed

NCT Number: NCT02196636

A Phase 1 Study of RO6806127 in Healthy Male Volunteers

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteer

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Marlton, New Jersey, 08053, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Matching placebo, administered orally with approximately 240 mL of buffer

RO6806127

Drug

Administered orally with approximately 240 mL of buffer

Primary outcomes

  1. Incidence of adverse events

    Time frame: Up to Day 21

Secondary outcomes

  1. Phamacokinetic profile of single-dose oral RO6806127 and its metabolites as appropriate, as assessed by concentrations over time in plasma and urine

    Time frame: Up to Day 21

  2. RO6806127 metabolite concentrations in selected plasma and urine samples

    Time frame: Up to Day 21

  3. Relative bioavailability (food effect): Area under the concentration-time curves [AUC]

    Time frame: Up to Day 21

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 22, 2014
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.