A Phase 1 Study of RO6806127 in Healthy Male Volunteers

NCT02196636 | Completed Phase 1

• 2 other identifiers: BP292762014-001019-38
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  Up to Day 21

Secondary Outcomes (3)

• 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

Study Arms (2)

Part 1: Single Ascending Dose (SAD)

EXPERIMENTAL

Adaptive model per protocol

Drug: Placebo; Drug: RO6806127

Part 2: Food Effect (FE)

EXPERIMENTAL

Fasted versus Fed

Drug: Placebo; Drug: RO6806127

Interventions

Placebo DRUG

Matching placebo, administered orally with approximately 240 mL of buffer

Part 1: Single Ascending Dose (SAD); Part 2: Food Effect (FE)

RO6806127 DRUG

Administered orally with approximately 240 mL of buffer

Part 1: Single Ascending Dose (SAD); Part 2: Food Effect (FE)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male participants aged 18 to 45 years, inclusive
• A BMI between 18 to 30 kg/m2, inclusive
• Agreement to use highly effective contraception

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Marlton, New Jersey, 08053, United States

Location

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2014
• First Posted: July 22, 2014
• Study Start: July 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

US (1)