Pharmacology, ClinicalPhase 1NCT00855660
Effect of Riociguat on Bone Metabolism
A Phase 1 study testing Riociguat (Adempas, BAY63-2521) immediate release tablet of 2.5 mg in people with Pharmacology, Clinical, run by Bayer at 1 site in Germany.
Trial summary
Investigation of the effect of Riociguat, administered as 2.5 mg IR-tablets TID over 14 days, on bone metabolism. 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
- Pharmacology, Clinical
- What is being tested?
- Riociguat (Adempas, BAY63-2521) immediate release tablet of 2.5 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2009to Jul 2010
- 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
- Healthy male white subjects
- 18 to 45 years of age
- BMI between 18 and 28 kg/m2
- Subjects who are able to understand and follow instructions and who are able to participate in the study for the entire period
Who cannot join
- Relevant deviation from the normal range in the clinical examination; in clinical chemistry, hematology, or urinalysis
- Resting heart rate in the awake subject below 45 BPM or above 90 BPM
- Systolic blood pressure below 100 mmHg or above 145 mmHg
- Diastolic blood pressure above 95 mmHg
- Relevant pathological changes in the ECG such as a second or third-degree AV block, prolongation of the QRS complex over 120 msec or of the QT / QTc-interval over 450 msec for males
- History of genetic muscle or bone disease of any kind
Show all 14Show fewer
- Completely sedentary or extremely fit subjects
- Fractures in the preceding 12 months
- Psychiatric diseases
- History of peptic ulcers or relevant gastro-esophageal reflux disease
- Subjects with hypersensitivity to the investigational drug riociguat or ranitidine, or to inactive constituents
- Regular daily consumption of more than half a liter of usual beer or the equivalent quantity of approximately 20 g of alcohol in another form, more than 1 L of xanthine-containing beverages, recent smoking history
- Use of medication within the 2 weeks preceding the study which could have interfered with the investigational drug riociguat or ranitidine
- Subjects with a medical disorder, condition or history of such that would have impaired the subject's ability to participate or complete this study in the opinion of the investigator or the sponsor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Riociguat, Administered as 2.5 mg IR-tablets TID Over 14 Days, on Bone Metabolism in a Randomized, Placebo-controlled, Double-blind, 2-fold Cross-over Design in Healthy Male Subjects
Investigation of the effect of Riociguat, administered as 2.5 mg IR-tablets TID over 14 days, on bone metabolism.
Read the detailed description
Clinical pharmacology
- Conditions
- Pharmacology, Clinical
- Being tested
- Riociguat (Adempas, BAY63-2521) immediate release tablet of 2.5 mg, Placebo
- Keywords
- Bone Metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Riociguat (Adempas, BAY63-2521) immediate release tablet of 2.5 mgDrug
Riociguat administered in a dose of 2.5 mg (single tablet), thrice daily, over 14 days.
PlaceboDrug
Placebo administered as a single tablet, thrice daily, over 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Riociguat | Active comparator | Subjects received multiple doses of riociguat (thrice a day) with concomitant administration of ranitidine (once daily) for 14 days Receives: Drug: Riociguat (Adempas, BAY63-2521) immediate release tablet of 2.5 mg |
| Placebo | Placebo comparator | Subjects received placebo (thrice a day) with concomitant administration of ranitidine (once daily) for 14 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary excretion (over 24 hours) of C-terminal cross-linking telopeptides of type I collagen (CTX)
Marker of bone resorption
Measured: From Day -01 to 16
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)
Measured: Pre-dose and up to 7 hours post-dose on Day 0
AUC(0-7)ss
AUC(0-7) at steady state
Measured: Pre-dose and up to 7 hours post-dose on Day 13
Cmax
Maximum drug concentration in plasma after single dose administration for riociguat and its metabolite M-1 (BAY60-4552)
Measured: Pre-dose and up to 7 hours post-dose on Day 0
Cmax,ss
Maximum drug concentration in plasma at steady state during a dosage interval for riociguat and its metabolite M-1 (BAY60-4552)
Measured: Pre-dose and up to 7 hours post-dose on Day 13
Secondary outcomes (24)
Number of participants with adverse events
Measured: Approximately 12 weeks
Ctrough
Drug concentration in plasma at expected time of minimum (trough) concentration for riociguat and its metabolite M-1 (BAY60-4552)
Measured: On Days 03 and 08
AUC(0-7)norm
AUC(0-7) divided by dose per kg body weight for riociguat and its metabolite M-1 (BAY60-4552)
Measured: Pre-dose and up to 7 hours post-dose on Day 0
AUC(0-7)ss,norm
AUC(0-7)ss divided by dose per kg body weight for riociguat and its metabolite M-1 (BAY60-4552)
Measured: Pre-dose and up to 7 hours post-dose on Day 13
Cmax,norm
Maximum 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)
Measured: Pre-dose and up to 7 hours post-dose on Day 0
Cmax,ss,norm
Maximum 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)
Measured: Pre-dose and up to 7 hours post-dose on Day 13
tmax
Time to reach maximum drug concentration in plasma after single (first) dose for riociguat and its metabolite M-1 (BAY60-4552)
Measured: Pre-dose and up to 7 hours post-dose on Day 0
tmax,ss
tmax at steady state for riociguat and its metabolite M-1 (BAY60-4552)
Measured: Pre-dose and up to 7 hours post-dose on Day 13
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)
Measured: Pre-dose and up to 7 hours post-dose
%Aeur(0-7)
Aeur(0-7) expressed as percent of dose administered for riociguat and its metabolite M-1 (BAY60-4552)
Measured: Pre-dose and up to 7 hours post-dose
Urinary excretion (over 24 hours) of N-terminal cross-linking telopeptides of type I collagen (NTX)
Marker of bone resorption
Measured: From -01 to 16 Days
Serum CTX
Marker of bone resorption
Measured: From -01 to 16 Days
Serum N-terminal propeptide of type I collagen (PINP)
Marker of bone formation
Measured: From -01 to 16 Days
Serum bone-specific alkaline phosphatase (bAP)
Marker of bone formation
Measured: From -01 to 16 Days
Serum albumin, protein
Determination of albumin, protein in serum
Measured: From -01 to 16 Days
Cyclic guanosine monophosphate (cGMP)
Determination of cGMP in plasma and urinary excretion (over 24 hours)
Measured: From -01 to 16 Days
Calcium, sodium, potassium
Determination of calcium, sodium, potassium in serum and urinary excretion (over 24 hours)
Measured: From -01 to 16 Days
Urine volume
Volume of urine excreted (over 24 hours)
Measured: From -01 to 16 Days
Renin
Determination of plasma renin level
Measured: From -01 to 16 Days
Creatinine clearance
For estimation of glomerular filtration rate
Measured: From -01 to 16 Days
Serum osteocalcin
Determination of osteocalcin in serum
Measured: From -01 to 16 Days
Creatinine
Determination of creatinine in serum and urinary excretion (over 24 hours)
Measured: From -01 to 16 Days
Phosphate
Determination of phosphate in serum only
Measured: From -01 to 16 Days
Parathyroid hormone (PTH)
Determination of PTH in serum only
Measured: From -01 to 16 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2009
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacology, ClinicalStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00855660
- Sponsor's protocol ID
- 13790
- Other IDs
- 2008-005569-70, 2008
- Status last verified
- Jan 2016
- First submitted
- 3 Mar 2009
- Last updated
- 11 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Riociguat, Administered as 2.5 mg IR-tablets TID Over 14 Days, on Bone Metabolism in a Randomized, Placebo-controlled, Double-blind, 2-fold Cross-over Design in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT00855660
- Acronym / sponsor ID
- 13790
- Conditions
- Pharmacology, Clinical
- Keywords
- Bone Metabolism
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 4 Mar 2009 (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.
Investigation of the effect of Riociguat, administered as 2.5 mg IR-tablets TID over 14 days, on bone metabolism.
Detailed description
Clinical pharmacology
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Riociguat | Active comparator | Drug: Riociguat (Adempas, BAY63-2521) immediate release tablet of 2.5 mgSubjects received multiple doses of riociguat (thrice a day) with concomitant administration of ranitidine (once daily) for 14 days |
| Placebo | Placebo comparator | Drug: PlaceboSubjects received placebo (thrice a day) with concomitant administration of ranitidine (once daily) for 14 days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male white subjects
- 18 to 45 years of age
- BMI between 18 and 28 kg/m2
- Subjects who are able to understand and follow instructions and who are able to participate in the study for the entire period
Key exclusion criteria (14 listed)
- Relevant deviation from the normal range in the clinical examination; in clinical chemistry, hematology, or urinalysis
- Resting heart rate in the awake subject below 45 BPM or above 90 BPM
- Systolic blood pressure below 100 mmHg or above 145 mmHg
- Diastolic blood pressure above 95 mmHg
- Relevant pathological changes in the ECG such as a second or third-degree AV block, prolongation of the QRS complex over 120 msec or of the QT / QTc-interval over 450 msec for males
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 |
|---|---|---|
| Riociguat (Adempas, BAY63-2521) immediate release tablet of 2.5 mgRiociguat administered in a dose of 2.5 mg (single tablet), thrice daily, over 14 days. | Drug | Riociguat |
| PlaceboPlacebo administered as a single tablet, thrice daily, over 14 days. | Drug | Placebo |
Primary outcome
Urinary excretion (over 24 hours) of C-terminal cross-linking telopeptides of type I collagen (CTX)
Time frame: From Day -01 to 16
Marker of bone resorption
AUC(0-7)
Time frame: Pre-dose and up to 7 hours post-dose on Day 0
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)
AUC(0-7)ss
Time frame: Pre-dose and up to 7 hours post-dose on Day 13
AUC(0-7) at steady state
Cmax
Time frame: Pre-dose and up to 7 hours post-dose on Day 0
Maximum drug concentration in plasma after single dose administration for riociguat and its metabolite M-1 (BAY60-4552)
Cmax,ss
Time frame: Pre-dose and up to 7 hours post-dose on Day 13
Maximum drug concentration in plasma at steady state during a dosage interval for riociguat and its metabolite M-1 (BAY60-4552)
24 secondary outcomes
Number of participants with adverse events
Time frame: Approximately 12 weeks
Ctrough
Time frame: On Days 03 and 08
AUC(0-7)norm
Time frame: Pre-dose and up to 7 hours post-dose on Day 0
AUC(0-7)ss,norm
Time frame: Pre-dose and up to 7 hours post-dose on Day 13
Cmax,norm
Time frame: Pre-dose and up to 7 hours post-dose on Day 0
Cmax,ss,norm
Time frame: Pre-dose and up to 7 hours post-dose on Day 13
tmax
Time frame: Pre-dose and up to 7 hours post-dose on Day 0
tmax,ss
Time frame: Pre-dose and up to 7 hours post-dose on Day 13
Aeur(0-7)
Time frame: Pre-dose and up to 7 hours post-dose
%Aeur(0-7)
Time frame: Pre-dose and up to 7 hours post-dose
Urinary excretion (over 24 hours) of N-terminal cross-linking telopeptides of type I collagen (NTX)
Time frame: From -01 to 16 Days
Serum CTX
Time frame: From -01 to 16 Days
Serum N-terminal propeptide of type I collagen (PINP)
Time frame: From -01 to 16 Days
Serum bone-specific alkaline phosphatase (bAP)
Time frame: From -01 to 16 Days
Serum albumin, protein
Time frame: From -01 to 16 Days
Cyclic guanosine monophosphate (cGMP)
Time frame: From -01 to 16 Days
Calcium, sodium, potassium
Time frame: From -01 to 16 Days
Urine volume
Time frame: From -01 to 16 Days
Renin
Time frame: From -01 to 16 Days
Creatinine clearance
Time frame: From -01 to 16 Days
Serum osteocalcin
Time frame: From -01 to 16 Days
Creatinine
Time frame: From -01 to 16 Days
Phosphate
Time frame: From -01 to 16 Days
Parathyroid hormone (PTH)
Time frame: From -01 to 16 Days
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 11 Jan 2016.
- Click here to find information about studies related to Bayer Healthcare products conducted in Europe.Link provided by the sponsor.
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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.
Bayer Study Director study director
Bayer
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 Riociguat (Adempas, BAY63-2521) immediate release tablet of 2.5 mg in people with Pharmacology, Clinical, run by Bayer at 1 site in Germany.
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 4 inclusion and 14 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 11 Jan 2016. 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 Germany. 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. Some participants in this study may receive a placebo. 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?
Urinary excretion (over 24 hours) of C-terminal cross-linking telopeptides of type I collagen (CTX) (time frame: From Day -01 to 16). The study lists 5 primary outcomes in all. 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 11 Jan 2016.