RAS-Peptide-Profile Study in Healthy Male Subjects (RAS)

May 8, 2013 updated by: University Hospital, Basel, Switzerland

Single-center, Randomized, Open-label, 3-way Crossover Study to Characterize the RAS-peptide-profile After Single and Repeated Oral Administration of Different RAS-inhibitors in Healthy Male Subjects

The primary objective is the characterization of the RAS peptide profiles after single and repeated oral administration of a renin inhibitor, an ACE inhibitor and an angiotensin receptor blocker in healthy volunteers.

Secondary objectives are the correlation of RAS peptide profiles with pharmacokinetic profiles of the different RAS inhibitors and with pharmacodynamic parameters such as blood pressure and heart rate. Output of the classic RAS system will be assessed using aldosterone concentrations. Fluid and sodium intake will be monitored using sodium concentration and total volume in 24h urine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The results of a pilot study have shown that single doses of different RAS inhibitors produce characteristic changes of the RAS peptide profiles. In a first step this finding needs to be verified in a larger number of healthy subjects. Since it is unknown, whether the changes that were observed within hours after a single inhibitor dose are stable over time, the profiles also need to be investigated under steady-state conditions of the different inhibitors. Comparison of RAS peptide profiles after single dose and under steady-state conditions will also allow to detect whether the peptide profiles are altered by compensatory mechanisms.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Department Clinical Pharmacology, University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male aged between 18 and 45 years (inclusive) at screening.
  • Body mass index (BMI) between 18 and 28 kg/m2 (inclusive) and body weight at least 50 kg at screening.
  • Systolic blood pressure (SBP) 100-140 mmHg, diastolic blood pressure (DBP) 60-90 mmHg and heart rate (HR) 45-90 bpm (inclusive), measured on the leading arm*, after 5 min in the supine position at screening.
  • Signed informed consent prior to any study-mandated procedure.
  • No clinically significant findings on the physical examination at screening.
  • 12-lead electrocardiogram (ECG) without clinically relevant abnormalities at screening.
  • Hematology and clinical chemistry results not deviating from the normal range to a clinically relevant extent at screening.

  • Ability to communicate well with the investigator and to understand and comply with the requirements of the study.

    • leading arm right = writing with right hand

Exclusion Criteria:

  • Smoking > 5 cigarettes per day
  • History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening.
  • Loss of ≥ 250 ml of blood within 3 months prior to screening.
  • Treatment with an investigational drug within 30 days prior to screening.
  • Previous treatment with any prescribed or over the counter medications (including herbal medicines such as St John's Wort) within 2 weeks prior to the intended start of study.
  • Legal incapacity or limited legal capacity at screening.
  • Positive results from urine drug screen at screening.
  • History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drugs, or which might increase the risk for toxicity.
  • Known hypersensitivity to any excipients of the drug formulations.
  • Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ACEI-ARB-RI
angiotensin converting enzyme inhibitor (ACEI) angiotensin receptor antagonist (ARB) renin inhibitor (RI)
Drug: ACEI-ARB-RI
Other Names:
  • angiotensin converting enzyme inhibitor (ACEI)
  • angiotensin receptor antagonist (ARB)
  • renin inhibitor (RI)
Drug: ARB-RI-ACEI
Other Names:
  • angiotensin converting enzyme inhibitor (ACEI)
  • angiotensin receptor antagonist (ARB)
  • renin inhibitor (RI)
Drug: RI-ACEI-ARB
Other Names:
  • angiotensin converting enzyme inhibitor (ACEI)
  • angiotensin receptor antagonist (ARB)
  • renin inhibitor (RI)
Experimental: ARB-RI-ACEI
Drug: ACEI-ARB-RI
Other Names:
  • angiotensin converting enzyme inhibitor (ACEI)
  • angiotensin receptor antagonist (ARB)
  • renin inhibitor (RI)
Drug: ARB-RI-ACEI
Other Names:
  • angiotensin converting enzyme inhibitor (ACEI)
  • angiotensin receptor antagonist (ARB)
  • renin inhibitor (RI)
Drug: RI-ACEI-ARB
Other Names:
  • angiotensin converting enzyme inhibitor (ACEI)
  • angiotensin receptor antagonist (ARB)
  • renin inhibitor (RI)
Experimental: RI-ACEI-ARB
Drug: ACEI-ARB-RI
Other Names:
  • angiotensin converting enzyme inhibitor (ACEI)
  • angiotensin receptor antagonist (ARB)
  • renin inhibitor (RI)
Drug: ARB-RI-ACEI
Other Names:
  • angiotensin converting enzyme inhibitor (ACEI)
  • angiotensin receptor antagonist (ARB)
  • renin inhibitor (RI)
Drug: RI-ACEI-ARB
Other Names:
  • angiotensin converting enzyme inhibitor (ACEI)
  • angiotensin receptor antagonist (ARB)
  • renin inhibitor (RI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
RAS-peptide profile
Time Frame: 0-192h
0-192h

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood pressure and heart rate
Time Frame: 0-192 h
0-192 h
Aldosterone concentrations
Time Frame: 0-192 h
0-192 h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Manuel Haschke, PD Dr. med., Clinical Pharmacology, University Hospital Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

January 16, 2013

First Submitted That Met QC Criteria

January 16, 2013

First Posted (Estimate)

January 18, 2013

Study Record Updates

Last Update Posted (Estimate)

May 13, 2013

Last Update Submitted That Met QC Criteria

May 8, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USBMH-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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