Skip to main content
OpenTrials
Completed

NCT Number: NCT01995383

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Marlton, New Jersey, 08053, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male volunteers, aged 18 to 45 years old.
  • No active or chronic disease following a detailed medical and surgical history and complete physical examination.
  • A BMI between 18 to 30 kg/m2 inclusive.
  • Use of a highly effective form of birth control for the duration of the study and until 90 days after the last dose.

Exclusion criteria

  • Any clinically relevant current or history of conditions or illnesses.
  • Clinically significant symptoms of infection within 5 days of the first dosing day or a history of recurrent infections.
  • Any suspicion or history of alcohol abuse and/or consumption of other drugs of abuse.
  • Smokers unable or unwilling to restrict to 5 cigarettes daily during the study and to not smoke during the stay at the clinic.
  • Any cardiac abnormalities.
  • Blood donation over 450 mL within three months prior to screening.
  • Participation in an investigational drug or device study within 3 months prior to dosing.
  • Corticosteroid use within 3 months prior to dosing.

Treatment and study plan

LS followed by NS diet condition

Other

LS diet period followed by NS diet period

NS followed by LS diet condition

Other

NS diet period followed by LS diet period

Placebo

Drug

Single oral administrations

RO6836191

Drug

Orally administered, single ascending doses

Primary outcomes

  1. Part 2: Area under the concentration-time curve (AUC)

    Time frame: Up to Day 35

  2. Part 2: Plasma aldosterone levels

    Time frame: Up to 2 days after drug administration

  3. Part 2: Urine aldosterone levels

    Time frame: Up to 3 days after drug administration

  4. Part 1: Plasma aldosterone levels

    Time frame: Up to Day 5

  5. Part 1: Urine aldosterone levels

    Time frame: Up to Day 3

  6. Part 2: Incidence of AEs

    Time frame: Up to 12 weeks

  7. Parts 1: Incidence of adverse events (AE)

    Time frame: Until Day 21

Secondary outcomes

  1. Part 2: Volume of distribution after intravenous administration

    Time frame: Days 28-37

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Single Oral Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO6836191 in Healthy Male Subjects Including a Single Intravenous Microdose of RO6836191

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 26, 2013
Registry last updated
Nov 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.