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

Primary Purpose

Atherosclerosis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

LS followed by NS diet condition

NS followed by LS diet condition

Placebo

RO6836191

About this trial

This is an interventional treatment trial for Atherosclerosis

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

Part 1: Placebo (PL)

Part 1: Single Ascending Doses (SAD) of RO6836191

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

Part 2: PL: NS followed by LS diet

Part 2: RO6836191: LS followed by NS diet

Part 2: RO6836191: NS followed by LS diet

Arm Description

Outcomes

Primary Outcome Measures

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

Part 2: Plasma aldosterone levels

Part 2: Urine aldosterone levels

Part 1: Plasma aldosterone levels

Part 1: Urine aldosterone levels

Part 2: Incidence of AEs

Parts 1: Incidence of adverse events (AE)

Secondary Outcome Measures

Part 2: Volume of distribution after intravenous administration

Full Information

NCT ID

NCT01995383

First Posted

November 20, 2013

Last Updated

November 3, 2016

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT01995383

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

November 2013 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atherosclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

88 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part 1: Placebo (PL)

Arm Type

Placebo Comparator

Arm Title

Part 1: Single Ascending Doses (SAD) of RO6836191

Arm Type

Experimental

Arm Title

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

Arm Type

Placebo Comparator

Arm Title

Part 2: PL: NS followed by LS diet

Arm Type

Placebo Comparator

Arm Title

Part 2: RO6836191: LS followed by NS diet

Arm Type

Experimental

Arm Title

Part 2: RO6836191: NS followed by LS diet

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

LS followed by NS diet condition

Intervention Description

LS diet period followed by NS diet period

Intervention Type

Other

Intervention Name(s)

NS followed by LS diet condition

Intervention Description

NS diet period followed by LS diet period

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Single oral administrations

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

2 single oral administrations

Intervention Type

Drug

Intervention Name(s)

RO6836191

Intervention Description

Orally administered, single ascending doses

Intervention Type

Drug

Intervention Name(s)

RO6836191

Intervention Description

2 single oral doses

Intervention Type

Drug

Intervention Name(s)

RO6836191

Intervention Description

Intravenous administration

Primary Outcome Measure Information:

Title

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

Time Frame

Up to Day 35

Title

Part 2: Plasma aldosterone levels

Time Frame

Up to 2 days after drug administration

Title

Part 2: Urine aldosterone levels

Time Frame

Up to 3 days after drug administration

Title

Part 1: Plasma aldosterone levels

Time Frame

Up to Day 5

Title

Part 1: Urine aldosterone levels

Time Frame

Up to Day 3

Title

Part 2: Incidence of AEs

Time Frame

Up to 12 weeks

Title

Parts 1: Incidence of adverse events (AE)

Time Frame

Until Day 21

Secondary Outcome Measure Information:

Title

Part 2: Volume of distribution after intravenous administration

Time Frame

Days 28-37

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

City

Marlton

State/Province

New Jersey

ZIP/Postal Code

08053

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

27872236

Citation

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.

Results Reference

derived

Learn more about this trial

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

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