NCT00855660

Brief Summary

Investigation of the effect of Riociguat, administered as 2.5 mg IR-tablets TID over 14 days, on bone metabolism.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

January 11, 2016

Status Verified

January 1, 2016

Enrollment Period

9 months

First QC Date

March 3, 2009

Last Update Submit

January 7, 2016

Conditions

Pharmacology, Clinical

Keywords

Bone Metabolism

Outcome Measures

Primary Outcomes (5)

  • Urinary excretion (over 24 hours) of C-terminal cross-linking telopeptides of type I collagen (CTX)

    Marker of bone resorption

    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)

    Pre-dose and up to 7 hours post-dose on Day 0

  • AUC(0-7)ss

    AUC(0-7) at steady state

    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)

    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)

    Pre-dose and up to 7 hours post-dose on Day 13

Secondary Outcomes (24)

  • Number of participants with adverse events

    Approximately 12 weeks

  • Ctrough

    On Days 03 and 08

  • AUC(0-7)norm

    Pre-dose and up to 7 hours post-dose on Day 0

  • AUC(0-7)ss,norm

    Pre-dose and up to 7 hours post-dose on Day 13

  • Cmax,norm

    Pre-dose and up to 7 hours post-dose on Day 0

  • +19 more secondary outcomes

Study Arms (2)

Riociguat

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

Subjects received placebo (thrice a day) with concomitant administration of ranitidine (once daily) for 14 days

Drug: Placebo

Interventions

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.

Riociguat
PlaceboDRUG

Placebo administered as a single tablet, thrice daily, over 14 days.

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male white subjects
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Cologne, North Rhine-Westphalia, 51147, Germany

Location

Related Links

MeSH Terms

Interventions

riociguat

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2009

First Posted

March 4, 2009

Study Start

March 1, 2009

Primary Completion

December 1, 2009

Study Completion

July 1, 2010

Last Updated

January 11, 2016

Record last verified: 2016-01

Locations

DE(1)