A Phase 1 Study of RO6806127 in Healthy Male Volunteers

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02196636

Enrollment

Registered

2014-07-22

Start date

2014-07-31

Completion date

2015-01-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

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.

Interventions

DRUGPlacebo

Matching placebo, administered orally with approximately 240 mL of buffer

DRUGRO6806127

Administered orally with approximately 240 mL of buffer

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Incidence of adverse events	Up to Day 21

Secondary

Measure	Time frame
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
RO6806127 metabolite concentrations in selected plasma and urine samples	Up to Day 21
Relative bioavailability (food effect): Area under the concentration-time curves [AUC]	Up to Day 21

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026