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

Atherosclerosis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01995383
• Other study ID #: WP28586
• Status: Completed
• Phase: Phase 1
• First received: November 20, 2013
• Last updated: November 3, 2016
• Start date: November 2013
• Est. completion date: June 2014

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: The Netherlands: De Centrale Commissie Mensgebonden Onderzoek
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Other:
• LS followed by NS diet condition
LS diet period followed by NS diet period
• NS followed by LS diet condition
NS diet period followed by LS diet period

Drug:
• Placebo
Single oral administrations
• Placebo
2 single oral administrations
• RO6836191
Orally administered, single ascending doses
• RO6836191
2 single oral doses
• RO6836191
Intravenous administration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 2: Area under the concentration-time curve (AUC)		Up to Day 35	No
Primary	Part 2: Plasma aldosterone levels		Up to 2 days after drug administration	No
Primary	Part 2: Urine aldosterone levels		Up to 3 days after drug administration	No
Primary	Part 1: Plasma aldosterone levels		Up to Day 5	No
Primary	Part 1: Urine aldosterone levels		Up to Day 3	No
Primary	Part 2: Incidence of AEs		Up to 12 weeks	No
Primary	Parts 1: Incidence of adverse events (AE)		Until Day 21	No
Secondary	Part 2: Volume of distribution after intravenous administration		Days 28-37	No