NCT01995383

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 26, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

November 4, 2016

Status Verified

November 1, 2016

Enrollment Period

7 months

First QC Date

November 20, 2013

Last Update Submit

November 3, 2016

Conditions

Atherosclerosis

Outcome Measures

Primary Outcomes (7)

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

    Up to Day 35

  • Part 2: Plasma aldosterone levels

    Up to 2 days after drug administration

  • Part 2: Urine aldosterone levels

    Up to 3 days after drug administration

  • Part 1: Plasma aldosterone levels

    Up to Day 5

  • Part 1: Urine aldosterone levels

    Up to Day 3

  • Part 2: Incidence of AEs

    Up to 12 weeks

  • Parts 1: Incidence of adverse events (AE)

    Until Day 21

Secondary Outcomes (1)

  • Part 2: Volume of distribution after intravenous administration

    Days 28-37

Study Arms (6)

Part 1: Placebo (PL)

PLACEBO COMPARATOR
Drug: Placebo

Part 1: Single Ascending Doses (SAD) of RO6836191

EXPERIMENTAL
Drug: RO6836191

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

PLACEBO COMPARATOR
Other: LS followed by NS diet conditionDrug: PlaceboDrug: RO6836191

Part 2: PL: NS followed by LS diet

PLACEBO COMPARATOR
Other: NS followed by LS diet conditionDrug: PlaceboDrug: RO6836191

Part 2: RO6836191: LS followed by NS diet

EXPERIMENTAL
Other: LS followed by NS diet conditionDrug: RO6836191

Part 2: RO6836191: NS followed by LS diet

EXPERIMENTAL
Other: NS followed by LS diet conditionDrug: RO6836191

Interventions

LS followed by NS diet conditionOTHER

LS diet period followed by NS diet period

Part 2: PL: Low-salt (LS) followed by normal-salt (NS) dietPart 2: RO6836191: LS followed by NS diet
NS followed by LS diet conditionOTHER

NS diet period followed by LS diet period

Part 2: PL: NS followed by LS dietPart 2: RO6836191: NS followed by LS diet
PlaceboDRUG

Single oral administrations

Part 1: Placebo (PL)
RO6836191DRUG

Orally administered, single ascending doses

Part 1: Single Ascending Doses (SAD) of RO6836191

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Marlton, New Jersey, 08053, United States

Location

Related Publications (1)

  • 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.

    PMID: 27872236DERIVED

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2013

First Posted

November 26, 2013

Study Start

November 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

November 4, 2016

Record last verified: 2016-11

Locations

US(1)