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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Atherosclerosis Other: LS followed by NS diet condition Other: NS followed by LS diet condition Drug: Placebo Drug: RO6836191 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : November 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Arm Intervention/treatment
Placebo Comparator: Part 1: Placebo (PL) Drug: Placebo
Single oral administrations

Experimental: Part 1: Single Ascending Doses (SAD) of RO6836191 Drug: RO6836191
Orally administered, single ascending doses

Placebo Comparator: Part 2: PL: Low-salt (LS) followed by normal-salt (NS) diet Other: LS followed by NS diet condition
LS diet period followed by NS diet period

Drug: Placebo
2 single oral administrations

Drug: RO6836191
Intravenous administration

Placebo Comparator: Part 2: PL: NS followed by LS diet Other: NS followed by LS diet condition
NS diet period followed by LS diet period

Drug: Placebo
2 single oral administrations

Drug: RO6836191
Intravenous administration

Experimental: Part 2: RO6836191: LS followed by NS diet Other: LS followed by NS diet condition
LS diet period followed by NS diet period

Drug: RO6836191
2 single oral doses

Drug: RO6836191
Intravenous administration

Experimental: Part 2: RO6836191: NS followed by LS diet Other: NS followed by LS diet condition
NS diet period followed by LS diet period

Drug: RO6836191
2 single oral doses

Drug: RO6836191
Intravenous administration




Primary Outcome Measures :
  1. Part 2: Area under the concentration-time curve (AUC) [ Time Frame: Up to Day 35 ]
  2. Part 2: Plasma aldosterone levels [ Time Frame: Up to 2 days after drug administration ]
  3. Part 2: Urine aldosterone levels [ Time Frame: Up to 3 days after drug administration ]
  4. Part 1: Plasma aldosterone levels [ Time Frame: Up to Day 5 ]
  5. Part 1: Urine aldosterone levels [ Time Frame: Up to Day 3 ]
  6. Part 2: Incidence of AEs [ Time Frame: Up to 12 weeks ]
  7. Parts 1: Incidence of adverse events (AE) [ Time Frame: Until Day 21 ]

Secondary Outcome Measures :
  1. Part 2: Volume of distribution after intravenous administration [ Time Frame: Days 28-37 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01995383


Locations
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United States, New Jersey
Marlton, New Jersey, United States, 08053
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01995383    
Other Study ID Numbers: WP28586
First Posted: November 26, 2013    Key Record Dates
Last Update Posted: November 4, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases