A Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of RO6864018 in Male, Healthy, Asian Participants

NCT02015715 | Completed Phase 1

• 1 other identifier: YP29017
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

This randomized, double-blind, placebo-controlled, single ascending dose study will assess the safety, pharmacokinetics, and pharmacodynamics of RO6864018 in healthy, male, Asian and Caucasian participants. Participants will be enrolled in cohorts and randomized 8:2 to receive a single oral administration of RO6864018 or placebo. Total study duration for each participant is up to 9 weeks.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  Baseline up to Day 29

Secondary Outcomes (36)

• Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0-inf) of RO6864018

  Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose

• AUC0-inf of Active Metabolite RO6871765

  Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose

• AUC0-inf of Prodrug Metabolite RO6870868

  Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose

• AUC0-inf of Minor Metabolite RO6872373

  Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose

• Area Under the Plasma Concentration Time Curve From Time Zero to Last Measurable Concentration (AUClast) of RO6864018

  Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose

Study Arms (2)

RO6864018

EXPERIMENTAL

Asian participants will receive a single oral dose of RO6864018 capsule on Day 1. The first dose escalation cohort will receive a single 400 mg oral dose. Dose will be escalated in subsequent cohorts (up to Cohort 4) up to a maximum of 1600 mg, based on safety, pharmacokinetic, and pharmacodynamic data available from lower dose cohorts. The Cohort 5 will include Caucasian participants who will receive a single 1200 mg (or the highest dose well-tolerated by Asian participants, if lower than 1200 mg) oral dose of RO6864018 capsules on Day 1.

Drug: RO6864018

Placebo

PLACEBO COMPARATOR

Participants will receive a single oral dose of placebo matching to RO6864018.

Drug: Placebo

Interventions

RO6864018 DRUG

A single oral ascending dose of RO6864018 capsules on Day 1.

RO6864018

Placebo DRUG

A single oral dose of placebo matching RO6864018 capsules on Day 1.

Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male participants of ethnic Chinese, Korean, Japanese origin or Caucasian
• No signs of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram (ECG), hematology, blood chemistry, serology and urinalysis
• Body Mass Index (BMI) between 18 to 30 kilograms per square meter (kg/m\^2) inclusive, and a weight range of 50 to 100 kilograms (kg) (110 to 220 pounds \[lb\]) inclusive at screening
• Non-smokers, or use of less than (\<) 10 cigarettes (or equivalent nicotine-containing product) per day

You may not qualify if:

• History or symptoms of any significant disease
• Personal or family history of congenital long QT syndrome or sudden death
• Any confirmed significant allergic reactions against any drug, or multiple drug allergies (non-active hay fever is acceptable)
• Positive results for anti-nuclear antibody (ANA), anti-mitochondrial antibody (AMA), anti-smooth muscle antibody (ASMA) and thyroid peroxidase antibody
• Suspicion of regular consumption of drug of abuse
• History (within 3 months of screening) of alcohol consumption exceeding 14 units per week on average (1 unit = 10 grams of alcohol)
• Participants who have received Interferon (IFN) or peginterferon within 8 weeks prior to dosing
• Use of any medication (prescription or over the counter \[OTC\], including health supplements and herbal remedies) within 2 weeks before the first dose of study medication
• Positive Hepatitis A immunoglobulin M antibody (HAV IgM Ab), Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab) or human immunodeficiency virus antibody (HIV Ab) at screening
• Donation or loss of blood of greater than 500 milliliters (mL) within 90 days prior to dosing
• Have participated in other clinical studies within 60 days prior to study randomization

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (2)

Changi General Hospital; Clinical Trial & Research unit

Singapore, 529889, Singapore

Location

Unknown Facility

Singapore, 529889, Singapore

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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2013
• First Posted: December 19, 2013
• Study Start: December 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: March 1, 2017

Record last verified: 2017-02

Locations

SG (2)