RAS Peptide Profile in Healthy VolunteersPhase 1RASNCT01771783
RAS-Peptide-Profile Study in Healthy Male Subjects
A Phase 1 study testing ACEI-ARB-RI, ARB-RI-ACEI and RI-ACEI-ARB in people with RAS Peptide Profile in Healthy Volunteers, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- RAS Peptide Profile in Healthy Volunteers
- What is being tested?
- ACEI-ARB-RI, ARB-RI-ACEI and RI-ACEI-ARB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2012to Apr 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department Clinical Pharmacology, University Hospital Basel
Basel, 4031
About this study
Official title: 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.
Read the 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.
- Being tested
- ACEI-ARB-RI, ARB-RI-ACEI, RI-ACEI-ARB
- Keywords
- RAS-Peptide Profile, Renin-Angiotensin-System, Angiotensin-Converting-Enzyme-Inhibitor, Angiotensin-Receptor-Antagonist, Renin-inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACEI-ARB-RIDrug
Also called angiotensin converting enzyme inhibitor (ACEI), angiotensin receptor antagonist (ARB), renin inhibitor (RI)
ARB-RI-ACEIDrug
Also called angiotensin converting enzyme inhibitor (ACEI), angiotensin receptor antagonist (ARB), renin inhibitor (RI)
RI-ACEI-ARBDrug
Also called angiotensin converting enzyme inhibitor (ACEI), angiotensin receptor antagonist (ARB), renin inhibitor (RI)
| Study group | Role | What they receive |
|---|---|---|
| ACEI-ARB-RI | Experimental | angiotensin converting enzyme inhibitor (ACEI) angiotensin receptor antagonist (ARB) renin inhibitor (RI) Receives: Drug: ACEI-ARB-RI; Drug: ARB-RI-ACEI; Drug: RI-ACEI-ARB |
| ARB-RI-ACEI | Experimental | ARB-RI-ACEI Receives: Drug: ACEI-ARB-RI; Drug: ARB-RI-ACEI; Drug: RI-ACEI-ARB |
| RI-ACEI-ARB | Experimental | RI-ACEI-ARB Receives: Drug: ACEI-ARB-RI; Drug: ARB-RI-ACEI; Drug: RI-ACEI-ARB |
What is being measured
The primary outcome is the main question the study is designed to answer.
RAS-peptide profile
Measured: 0-192h
Secondary outcomes (2)
Blood pressure and heart rate
Measured: 0-192 h
Aldosterone concentrations
Measured: 0-192 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startNov 2012
- Primary completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RAS Peptide Profile in Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manuel Haschke, PD Dr. med., Principal investigator, Clinical Pharmacology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01771783
- Sponsor's protocol ID
- USBMH-001
- Acronym
- RAS
- Status last verified
- May 2013
- First submitted
- 16 Jan 2013
- Last updated
- 13 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01771783
- Acronym / sponsor ID
- RAS / USBMH-001
- Keywords
- RAS-Peptide Profile, Renin-Angiotensin-System, Angiotensin-Converting-Enzyme-Inhibitor, Angiotensin-Receptor-Antagonist, Renin-inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Apr 2013 (actual)
- First posted
- 18 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ACEI-ARB-RI | Experimental | Drug: ACEI-ARB-RI, Drug: ARB-RI-ACEI, Drug: RI-ACEI-ARBangiotensin converting enzyme inhibitor (ACEI) angiotensin receptor antagonist (ARB) renin inhibitor (RI) |
| ARB-RI-ACEI | Experimental | Drug: ACEI-ARB-RI, Drug: ARB-RI-ACEI, Drug: RI-ACEI-ARBARB-RI-ACEI |
| RI-ACEI-ARB | Experimental | Drug: ACEI-ARB-RI, Drug: ARB-RI-ACEI, Drug: RI-ACEI-ARBRI-ACEI-ARB |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACEI-ARB-RIAlso: angiotensin converting enzyme inhibitor (ACEI), angiotensin receptor antagonist (ARB), renin inhibitor (RI) | Drug | ACEI-ARB-RI, ARB-RI-ACEI, RI-ACEI-ARB |
| ARB-RI-ACEIAlso: angiotensin converting enzyme inhibitor (ACEI), angiotensin receptor antagonist (ARB), renin inhibitor (RI) | Drug | ACEI-ARB-RI, ARB-RI-ACEI, RI-ACEI-ARB |
| RI-ACEI-ARBAlso: angiotensin converting enzyme inhibitor (ACEI), angiotensin receptor antagonist (ARB), renin inhibitor (RI) | Drug | ACEI-ARB-RI, ARB-RI-ACEI, RI-ACEI-ARB |
Primary outcome
RAS-peptide profile
Time frame: 0-192h
2 secondary outcomes
Blood pressure and heart rate
Time frame: 0-192 h
Aldosterone concentrations
Time frame: 0-192 h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel Haschke, PD Dr. med. principal investigator
Clinical Pharmacology, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ACEI-ARB-RI, ARB-RI-ACEI and RI-ACEI-ARB in people with RAS Peptide Profile in Healthy Volunteers, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RAS-peptide profile (time frame: 0-192h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2013.