Effect of Riociguat on Bone Metabolism

January 7, 2016 updated by: Bayer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Clinical pharmacology

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Germany
    • Nordrhein-Westfalen
      • Köln, Nordrhein-Westfalen, Germany, 51147

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Riociguat
Subjects received multiple doses of riociguat (thrice a day) with concomitant administration of ranitidine (once daily) for 14 days
Drug: Riociguat (Adempas, BAY63-2521) immediate release tablet of 2.5 mg
Riociguat administered in a dose of 2.5 mg (single tablet), thrice daily, over 14 days.
Placebo Comparator: Placebo
Subjects received placebo (thrice a day) with concomitant administration of ranitidine (once daily) for 14 days
Drug: Placebo
Placebo administered as a single tablet, thrice daily, over 14 days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
From Day -01 to 16
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)
Pre-dose and up to 7 hours post-dose on Day 0
AUC(0-7)ss
Time Frame: Pre-dose and up to 7 hours post-dose on Day 13
AUC(0-7) at steady state
Pre-dose and up to 7 hours post-dose on Day 13
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)
Pre-dose and up to 7 hours post-dose on Day 0
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)
Pre-dose and up to 7 hours post-dose on Day 13

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events
Time Frame: Approximately 12 weeks
Approximately 12 weeks
Ctrough
Time Frame: On Days 03 and 08
Drug concentration in plasma at expected time of minimum (trough) concentration for riociguat and its metabolite M-1 (BAY60-4552)
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) divided by dose per kg body weight for riociguat and its metabolite M-1 (BAY60-4552)
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
AUC(0-7)ss divided by dose per kg body weight for riociguat and its metabolite M-1 (BAY60-4552)
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
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)
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
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)
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
Time to reach maximum drug concentration in plasma after single (first) dose for riociguat and its metabolite M-1 (BAY60-4552)
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
tmax at steady state for riociguat and its metabolite M-1 (BAY60-4552)
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
Amount of drug excreted via urine from zero to 7 hours after administration for riociguat and its metabolite M-1 (BAY60-4552)
Pre-dose and up to 7 hours post-dose
%Aeur(0-7)
Time Frame: Pre-dose and up to 7 hours post-dose
Aeur(0-7) expressed as percent of dose administered for riociguat and its metabolite M-1 (BAY60-4552)
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
Marker of bone resorption
From -01 to 16 Days
Serum CTX
Time Frame: From -01 to 16 Days
Marker of bone resorption
From -01 to 16 Days
Serum N-terminal propeptide of type I collagen (PINP)
Time Frame: From -01 to 16 Days
Marker of bone formation
From -01 to 16 Days
Serum bone-specific alkaline phosphatase (bAP)
Time Frame: From -01 to 16 Days
Marker of bone formation
From -01 to 16 Days
Serum albumin, protein
Time Frame: From -01 to 16 Days
Determination of albumin, protein in serum
From -01 to 16 Days
Cyclic guanosine monophosphate (cGMP)
Time Frame: From -01 to 16 Days
Determination of cGMP in plasma and urinary excretion (over 24 hours)
From -01 to 16 Days
Calcium, sodium, potassium
Time Frame: From -01 to 16 Days
Determination of calcium, sodium, potassium in serum and urinary excretion (over 24 hours)
From -01 to 16 Days
Urine volume
Time Frame: From -01 to 16 Days
Volume of urine excreted (over 24 hours)
From -01 to 16 Days
Renin
Time Frame: From -01 to 16 Days
Determination of plasma renin level
From -01 to 16 Days
Creatinine clearance
Time Frame: From -01 to 16 Days
For estimation of glomerular filtration rate
From -01 to 16 Days
Serum osteocalcin
Time Frame: From -01 to 16 Days
Determination of osteocalcin in serum
From -01 to 16 Days
Creatinine
Time Frame: From -01 to 16 Days
Determination of creatinine in serum and urinary excretion (over 24 hours)
From -01 to 16 Days
Phosphate
Time Frame: From -01 to 16 Days
Determination of phosphate in serum only
From -01 to 16 Days
Parathyroid hormone (PTH)
Time Frame: From -01 to 16 Days
Determination of PTH in serum only
From -01 to 16 Days

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 11, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 13790
  • 2008-005569-70 (EudraCT Number)

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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