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A Single Ascending Dose Study Investigating the Safety, Pharmacokinetics and Pharmacodynamics of RO6836191 in Healthy Male Volunteers.

NCT01995383 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2016-11-04

No results posted yet for this study

Summary

This single-center, randomized, placebo-controlled, double-blind study will assess the safety, pharmacokinetics and pharmacodynamics of RO6836191 in healthy male volunteers in two parts. Part 1 will assess the safety of oral single ascending doses of RO6836191 compared to placebo in fasted volunteers. In Part 2, participants will be given two single oral doses of RO6836191 or placebo under low or normal-salt diet conditions. A subset of these participants will subsequently receive a single IV dose of RO6836191 for further analysis.

Conditions

Interventions

OTHER

LS followed by NS diet condition

LS diet period followed by NS diet period

OTHER

NS followed by LS diet condition

NS diet period followed by LS diet period

DRUG

Placebo

Single oral administrations

DRUG

Placebo

2 single oral administrations

DRUG

RO6836191

Orally administered, single ascending doses

DRUG

RO6836191

2 single oral doses

DRUG

RO6836191

Intravenous administration

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01995383 on ClinicalTrials.gov