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A Phase 1 Study of RO6806127 in Healthy Male Volunteers

NCT ID: NCT02196636

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-01-31

Brief Summary

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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

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part 1: Single Ascending Dose (SAD)

Adaptive model per protocol

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Matching placebo, administered orally with approximately 240 mL of buffer

RO6806127

Intervention Type DRUG

Administered orally with approximately 240 mL of buffer

Part 2: Food Effect (FE)

Fasted versus Fed

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Matching placebo, administered orally with approximately 240 mL of buffer

RO6806127

Intervention Type DRUG

Administered orally with approximately 240 mL of buffer

Interventions

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Placebo

Matching placebo, administered orally with approximately 240 mL of buffer

Intervention Type DRUG

RO6806127

Administered orally with approximately 240 mL of buffer

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Marlton, New Jersey, United States

Site Status

Countries

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Netherlands United States

Other Identifiers

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2014-001019-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BP29276

Identifier Type: -

Identifier Source: org_study_id