Healthy VolunteersPhase 1NCT02159313
Relative Bioavailability Study
A Phase 1 study testing Riociguat(Adempas,BAY63-2521) in people with Healthy Volunteers, run by Bayer at 1 site in Germany.
Trial summary
To investigate relative bioavailability of crushed tablets suspended in apple sauce or water 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
- Healthy Volunteers
- What is being tested?
- Riociguat(Adempas,BAY63-2521)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2014to Jan 2015
- 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 subject
- Age: 18 to 45 years (inclusive) at the first screening examination
- Ethnicity: white
- Body mass index (BMI): >18 and <29.9 kg/m2
Who cannot join
- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, or effects of the study drug will not be normal
- History of coronary artery disease
- Symptomatic postural hypotension (e.g. dizziness, lightheadedness)
- History of bronchial asthma or any other airway disease
- Smoking (former smokers who have stopped smoking at least 3 months before the first study drug administration may be included)
- Clinically relevant findings in the ECG such as a second- or third-degree atrioventricular block, prolongation of the QRS complex over 120 ms or of the QTc interval (QT interval corrected for heart rate) over 450 ms
Show all 9Show fewer
- Systolic blood pressure below 100 or above 145 mmHg
- Diastolic blood pressure below 50 or above 95 mmHg
- Heart rate below 45 or above 95 beats per minute
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relative Bioavailability Study of Riociguat Given Orally as a Crushed 2.5 mg Tablet Suspended in Applesauce, Crushed 2.5 mg Tablet Suspended in Water, and Whole 2.5 mg Tablet After a Continental Breakfast in Comparison to a Whole 2.5 mg Tablet Given in the Fasted State to Characterize the Pharmacokinetic Properties in Healthy Male Adult Subjects in a 4-fold Crossover Design
To investigate relative bioavailability of crushed tablets suspended in apple sauce or water
- Conditions
- Healthy Volunteers
- Being tested
- Riociguat(Adempas,BAY63-2521)
- Keywords
- Biological Availability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Riociguat(Adempas,BAY63-2521)Drug
Single dose of a whole 2.5 mg riociguat tablet
| Study group | Role | What they receive |
|---|---|---|
| BAY63-2521 with Non sparkling water | Experimental | Single dose of a whole 2.5 mg riociguat tablet (fasted) with 240 mL of non-sparkling water at room temperature Receives: Drug: Riociguat(Adempas,BAY63-2521) |
| BAY63-2521 with applesauce | Experimental | Single dose of a crushed 2.5 mg riociguat tablet suspended in 50 mL applesauce, to be eaten with a spoon (fasted) Receives: Drug: Riociguat(Adempas,BAY63-2521) |
| BAY63-2521 with water | Experimental | Single dose of a crushed 2.5 mg riociguat tablet suspended in a glass with 25 mL water, to be drunk and flushed twice with 25 mL water in the same glass (fasted) Receives: Drug: Riociguat(Adempas,BAY63-2521) |
| BAY63-2521 after breakfast | Experimental | Single dose of a whole 2.5 mg riociguat tablet taken within 5 minutes after the last bite of a continental breakfast (fed) with 240 mL of non-sparkling water at room temperature Receives: Drug: Riociguat(Adempas,BAY63-2521) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of riociguat in plasma by Area under the plasma concentration time curve (AUC)
Measured: Multiple time points up to day 3
Pharmacokinetics of riociguat in plasma by maximal concentration (Cmax)
Measured: Multiple time ponits up to day 3
Secondary outcomes (1)
Number of participants with adverse events as a measure of safety and tolerability
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 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
- NCT02159313
- Sponsor's protocol ID
- 17306
- Other IDs
- 2013-005166-18
- Status last verified
- Feb 2016
- First submitted
- 6 Jun 2014
- Last updated
- 18 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Bioavailability Study of Riociguat Given Orally as a Crushed 2.5 mg Tablet Suspended in Applesauce, Crushed 2.5 mg Tablet Suspended in Water, and Whole 2.5 mg Tablet After a Continental Breakfast in Comparison to a Whole 2.5 mg Tablet Given in the Fasted State to Characterize the Pharmacokinetic Properties in Healthy Male Adult Subjects in a 4-fold Crossover Design
- ClinicalTrials.gov ID
- NCT02159313
- Acronym / sponsor ID
- 17306
- Conditions
- Healthy Volunteers
- Keywords
- Biological Availability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 9 Jun 2014 (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.
To investigate relative bioavailability of crushed tablets suspended in apple sauce or water
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BAY63-2521 with Non sparkling water | Experimental | Drug: Riociguat(Adempas,BAY63-2521)Single dose of a whole 2.5 mg riociguat tablet (fasted) with 240 mL of non-sparkling water at room temperature |
| BAY63-2521 with applesauce | Experimental | Drug: Riociguat(Adempas,BAY63-2521)Single dose of a crushed 2.5 mg riociguat tablet suspended in 50 mL applesauce, to be eaten with a spoon (fasted) |
| BAY63-2521 with water | Experimental | Drug: Riociguat(Adempas,BAY63-2521)Single dose of a crushed 2.5 mg riociguat tablet suspended in a glass with 25 mL water, to be drunk and flushed twice with 25 mL water in the same glass (fasted) |
| BAY63-2521 after breakfast | Experimental | Drug: Riociguat(Adempas,BAY63-2521)Single dose of a whole 2.5 mg riociguat tablet taken within 5 minutes after the last bite of a continental breakfast (fed) with 240 mL of non-sparkling water at room temperature |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subject
- Age: 18 to 45 years (inclusive) at the first screening examination
- Ethnicity: white
- Body mass index (BMI): >18 and <29.9 kg/m2
Key exclusion criteria (9 listed)
- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, or effects of the study drug will not be normal
- History of coronary artery disease
- Symptomatic postural hypotension (e.g. dizziness, lightheadedness)
- History of bronchial asthma or any other airway disease
- Smoking (former smokers who have stopped smoking at least 3 months before the first study drug administration may be included)
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)Single dose of a whole 2.5 mg riociguat tablet | Drug | BAY63-2521 after breakfast, BAY63-2521 with Non sparkling water, BAY63-2521 with applesauce, BAY63-2521 with water |
Primary outcome
Pharmacokinetics of riociguat in plasma by Area under the plasma concentration time curve (AUC)
Time frame: Multiple time points up to day 3
Pharmacokinetics of riociguat in plasma by maximal concentration (Cmax)
Time frame: Multiple time ponits up to day 3
1 secondary outcome
Number of participants with adverse events as a measure of safety and tolerability
Time frame: Up to 12 weeks
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 18 Feb 2016.
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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) in people with Healthy Volunteers, 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 9 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 18 Feb 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. 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?
Pharmacokinetics of riociguat in plasma by Area under the plasma concentration time curve (AUC) (time frame: Multiple time points up to day 3). The study lists 2 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 18 Feb 2016.