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

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ClinicalTrials.gov Identifier: NCT01995383
Recruitment Status : Completed
First Posted : November 26, 2013
Last Update Posted : November 4, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE November 20, 2013
First Posted Date  ICMJE November 26, 2013
Last Update Posted Date November 4, 2016
Study Start Date  ICMJE November 2013
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2016)
  • Part 2: Area under the concentration-time curve (AUC) [ Time Frame: Up to Day 35 ]
  • Part 2: Plasma aldosterone levels [ Time Frame: Up to 2 days after drug administration ]
  • Part 2: Urine aldosterone levels [ Time Frame: Up to 3 days after drug administration ]
  • Part 1: Plasma aldosterone levels [ Time Frame: Up to Day 5 ]
  • Part 1: Urine aldosterone levels [ Time Frame: Up to Day 3 ]
  • Part 2: Incidence of AEs [ Time Frame: Up to 12 weeks ]
  • Parts 1: Incidence of adverse events (AE) [ Time Frame: Until Day 21 ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 25, 2013)
  • Parts 1: Incidence of adverse events (AE) [ Time Frame: Until Day 21 ]
  • Part 2: Area under the concentration-time curve (AUC) [ Time Frame: Up to Day 35 ]
  • Part 2: Plasma aldosterone levels [ Time Frame: Up to 2 days after drug administration ]
  • Part 2: Urine aldosterone levels [ Time Frame: Up to 3 days after drug administration ]
  • Part 1: Plasma aldosterone levels [ Time Frame: Up to Day 5 ]
  • Part 1: Urine aldosterone levels [ Time Frame: Up to Day 3 ]
  • Part 2: Incidence of AEs [ Time Frame: Up to 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2013)
Part 2: Volume of distribution after intravenous administration [ Time Frame: Days 28-37 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Single Ascending Dose Study Investigating the Safety, Pharmacokinetics and Pharmacodynamics of RO6836191 in Healthy Male Volunteers.
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Atherosclerosis
Intervention  ICMJE
  • Other: LS followed by NS diet condition
    LS diet period followed by NS diet period
  • Other: NS followed by LS diet condition
    NS diet period followed by LS diet period
  • Drug: Placebo
    Single oral administrations
  • Drug: Placebo
    2 single oral administrations
  • Drug: RO6836191
    Orally administered, single ascending doses
  • Drug: RO6836191
    2 single oral doses
  • Drug: RO6836191
    Intravenous administration
Study Arms  ICMJE
  • Placebo Comparator: Part 1: Placebo (PL)
    Intervention: Drug: Placebo
  • Experimental: Part 1: Single Ascending Doses (SAD) of RO6836191
    Intervention: Drug: RO6836191
  • Placebo Comparator: Part 2: PL: Low-salt (LS) followed by normal-salt (NS) diet
    Interventions:
    • Other: LS followed by NS diet condition
    • Drug: Placebo
    • Drug: RO6836191
  • Placebo Comparator: Part 2: PL: NS followed by LS diet
    Interventions:
    • Other: NS followed by LS diet condition
    • Drug: Placebo
    • Drug: RO6836191
  • Experimental: Part 2: RO6836191: LS followed by NS diet
    Interventions:
    • Other: LS followed by NS diet condition
    • Drug: RO6836191
    • Drug: RO6836191
  • Experimental: Part 2: RO6836191: NS followed by LS diet
    Interventions:
    • Other: NS followed by LS diet condition
    • Drug: RO6836191
    • Drug: RO6836191
Publications * 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. Epub 2016 Nov 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 3, 2016)
88
Original Estimated Enrollment  ICMJE
 (submitted: November 25, 2013)
96
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Netherlands
 
Administrative Information
NCT Number  ICMJE NCT01995383
Other Study ID Numbers  ICMJE WP28586
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP