- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01771783
RAS-Peptide-Profile Study in Healthy Male Subjects (RAS)
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 1
Kontakter och platser
Studieorter
-
-
-
Basel, Schweiz, 4031
- Department Clinical Pharmacology, University Hospital Basel
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: ACEI-ARB-RI
angiotensin converting enzyme inhibitor (ACEI) angiotensin receptor antagonist (ARB) renin inhibitor (RI)
|
Andra namn:
Andra namn:
Andra namn:
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Experimentell: ARB-RI-ACEI
|
Andra namn:
Andra namn:
Andra namn:
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Experimentell: RI-ACEI-ARB
|
Andra namn:
Andra namn:
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
RAS-peptide profile
Tidsram: 0-192h
|
0-192h
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Blood pressure and heart rate
Tidsram: 0-192 h
|
0-192 h
|
Aldosterone concentrations
Tidsram: 0-192 h
|
0-192 h
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Manuel Haschke, PD Dr. med., Clinical Pharmacology, University Hospital Basel
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- USBMH-001
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