check_circleStudy Completed
Pharmacology, clinical
Bayer Identifier:
13790
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Effect of Riociguat on bone metabolism
Trial purpose
Investigation of the effect of Riociguat, administered as 2.5 mg IR-tablets TID over 14 days, on bone metabolism.
Key Participants Requirements
Sex
MaleAge
18 - 45 YearsTrial summary
Enrollment Goal
17Trial Dates
March 2009 - July 2010Phase
Phase 1Could I Receive a placebo
YesProducts
Adempas (Riociguat, BAY63-2521)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Deutsches Zentrum für Luft- und Raumfahrt e. V. (DLR) | Köln, 51147, Germany |
Primary Outcome
- Urinary excretion (over 24 hours) of C-terminal cross-linking telopeptides of type I collagen (CTX)Marker of bone resorptiondate_rangeTime Frame:From Day -01 to 16enhanced_encryptionNoSafety Issue:
- AUC(0-7)Area under the plasma concentration vs time curve (AUC) from zero to 7 hours after single (first) dose for riociguat and its metabolite M-1 (BAY60-4552)date_rangeTime Frame:Pre-dose and up to 7 hours post-dose on Day 0enhanced_encryptionNoSafety Issue:
- AUC(0-7)ssAUC(0-7) at steady statedate_rangeTime Frame:Pre-dose and up to 7 hours post-dose on Day 13enhanced_encryptionNoSafety Issue:
- CmaxMaximum drug concentration in plasma after single dose administration for riociguat and its metabolite M-1 (BAY60-4552)date_rangeTime Frame:Pre-dose and up to 7 hours post-dose on Day 0enhanced_encryptionNoSafety Issue:
- Cmax,ssMaximum drug concentration in plasma at steady state during a dosage interval for riociguat and its metabolite M-1 (BAY60-4552)date_rangeTime Frame:Pre-dose and up to 7 hours post-dose on Day 13enhanced_encryptionNoSafety Issue:
Secondary Outcome
- Number of participants with adverse eventsdate_rangeTime Frame:Approximately 12 weeksenhanced_encryptionyesSafety Issue:
- CtroughDrug concentration in plasma at expected time of minimum (trough) concentration for riociguat and its metabolite M-1 (BAY60-4552)date_rangeTime Frame:On Days 03 and 08enhanced_encryptionNoSafety Issue:
- AUC(0-7)normAUC(0-7) divided by dose per kg body weight for riociguat and its metabolite M-1 (BAY60-4552)date_rangeTime Frame:Pre-dose and up to 7 hours post-dose on Day 0enhanced_encryptionNoSafety Issue:
- AUC(0-7)ss,normAUC(0-7)ss divided by dose per kg body weight for riociguat and its metabolite M-1 (BAY60-4552)date_rangeTime Frame:Pre-dose and up to 7 hours post-dose on Day 13enhanced_encryptionNoSafety Issue:
- Cmax,normMaximum drug concentration in plasma after (first) single dose administration divided by dose (mg) per kg body weight for riociguat and its metabolite M-1 (BAY60-4552)date_rangeTime Frame:Pre-dose and up to 7 hours post-dose on Day 0enhanced_encryptionNoSafety Issue:
- Cmax,ss,normMaximum drug concentration in plasma at steady state during a dosage interval divided by dose (mg) per kg body weight for riociguat and its metabolite M-1 (BAY60-4552)date_rangeTime Frame:Pre-dose and up to 7 hours post-dose on Day 13enhanced_encryptionNoSafety Issue:
- tmaxTime to reach maximum drug concentration in plasma after single (first) dose for riociguat and its metabolite M-1 (BAY60-4552)date_rangeTime Frame:Pre-dose and up to 7 hours post-dose on Day 0enhanced_encryptionNoSafety Issue:
- tmax,sstmax at steady state for riociguat and its metabolite M-1 (BAY60-4552)date_rangeTime Frame:Pre-dose and up to 7 hours post-dose on Day 13enhanced_encryptionNoSafety Issue:
- Aeur(0-7)Amount of drug excreted via urine from zero to 7 hours after administration for riociguat and its metabolite M-1 (BAY60-4552)date_rangeTime Frame:Pre-dose and up to 7 hours post-doseenhanced_encryptionNoSafety Issue:
- %Aeur(0-7)Aeur(0-7) expressed as percent of dose administered for riociguat and its metabolite M-1 (BAY60-4552)date_rangeTime Frame:Pre-dose and up to 7 hours post-doseenhanced_encryptionNoSafety Issue:
- Urinary excretion (over 24 hours) of N-terminal cross-linking telopeptides of type I collagen (NTX)Marker of bone resorptiondate_rangeTime Frame:From -01 to 16 Daysenhanced_encryptionNoSafety Issue:
- Serum CTXMarker of bone resorptiondate_rangeTime Frame:From -01 to 16 Daysenhanced_encryptionNoSafety Issue:
- Serum N-terminal propeptide of type I collagen (PINP)Marker of bone formationdate_rangeTime Frame:From -01 to 16 Daysenhanced_encryptionNoSafety Issue:
- Serum bone-specific alkaline phosphatase (bAP)Marker of bone formationdate_rangeTime Frame:From -01 to 16 Daysenhanced_encryptionNoSafety Issue:
- Serum albumin, proteinDetermination of albumin, protein in serumdate_rangeTime Frame:From -01 to 16 Daysenhanced_encryptionNoSafety Issue:
- Cyclic guanosine monophosphate (cGMP)Determination of cGMP in plasma and urinary excretion (over 24 hours)date_rangeTime Frame:From -01 to 16 Daysenhanced_encryptionNoSafety Issue:
- Calcium, sodium, potassiumDetermination of calcium, sodium, potassium in serum and urinary excretion (over 24 hours)date_rangeTime Frame:From -01 to 16 Daysenhanced_encryptionNoSafety Issue:
- Urine volumeVolume of urine excreted (over 24 hours)date_rangeTime Frame:From -01 to 16 Daysenhanced_encryptionNoSafety Issue:
- ReninDetermination of plasma renin leveldate_rangeTime Frame:From -01 to 16 Daysenhanced_encryptionNoSafety Issue:
- Creatinine clearanceFor estimation of glomerular filtration ratedate_rangeTime Frame:From -01 to 16 Daysenhanced_encryptionNoSafety Issue:
- Serum osteocalcinDetermination of osteocalcin in serumdate_rangeTime Frame:From -01 to 16 Daysenhanced_encryptionNoSafety Issue:
- CreatinineDetermination of creatinine in serum and urinary excretion (over 24 hours)date_rangeTime Frame:From -01 to 16 Daysenhanced_encryptionNoSafety Issue:
- PhosphateDetermination of phosphate in serum onlydate_rangeTime Frame:From -01 to 16 Daysenhanced_encryptionNoSafety Issue:
- Parathyroid hormone (PTH)Determination of PTH in serum onlydate_rangeTime Frame:From -01 to 16 Daysenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Crossover AssignmentTrial Arms
2Additional Information
Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.Click here to find information about studies related to Bayer Healthcare products conducted in Europe.