MedDataX Logo

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

NCT ID: NCT01995383

Last Updated: 2016-11-04

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atherosclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Part 1: Placebo (PL)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single oral administrations

Part 1: Single Ascending Doses (SAD) of RO6836191

Group Type EXPERIMENTAL

RO6836191

Intervention Type DRUG

Orally administered, single ascending doses

Part 2: PL: Low-salt (LS) followed by normal-salt (NS) diet

Group Type PLACEBO_COMPARATOR

LS followed by NS diet condition

Intervention Type OTHER

LS diet period followed by NS diet period

Placebo

Intervention Type DRUG

2 single oral administrations

RO6836191

Intervention Type DRUG

Intravenous administration

Part 2: PL: NS followed by LS diet

Group Type PLACEBO_COMPARATOR

NS followed by LS diet condition

Intervention Type OTHER

NS diet period followed by LS diet period

Placebo

Intervention Type DRUG

2 single oral administrations

RO6836191

Intervention Type DRUG

Intravenous administration

Part 2: RO6836191: LS followed by NS diet

Group Type EXPERIMENTAL

LS followed by NS diet condition

Intervention Type OTHER

LS diet period followed by NS diet period

RO6836191

Intervention Type DRUG

2 single oral doses

RO6836191

Intervention Type DRUG

Intravenous administration

Part 2: RO6836191: NS followed by LS diet

Group Type EXPERIMENTAL

NS followed by LS diet condition

Intervention Type OTHER

NS diet period followed by LS diet period

RO6836191

Intervention Type DRUG

2 single oral doses

RO6836191

Intervention Type DRUG

Intravenous administration

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LS followed by NS diet condition

LS diet period followed by NS diet period

Intervention Type OTHER

NS followed by LS diet condition

NS diet period followed by LS diet period

Intervention Type OTHER

Placebo

Single oral administrations

Intervention Type DRUG

Placebo

2 single oral administrations

Intervention Type DRUG

RO6836191

Orally administered, single ascending doses

Intervention Type DRUG

RO6836191

2 single oral doses

Intervention Type DRUG

RO6836191

Intravenous administration

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Marlton, New Jersey, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands United States

References

Explore related publications, articles, or registry entries linked to this study.

Bogman K, Schwab D, Delporte ML, Palermo G, Amrein K, Mohr S, De Vera Mudry MC, Brown MJ, Ferber P. Preclinical and Early Clinical Profile of a Highly Selective and Potent Oral Inhibitor of Aldosterone Synthase (CYP11B2). Hypertension. 2017 Jan;69(1):189-196. doi: 10.1161/HYPERTENSIONAHA.116.07716. Epub 2016 Nov 21.

Reference Type DERIVED
PMID: 27872236 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

WP28586

Identifier Type: -

Identifier Source: org_study_id