Clinical Trials, Phase I as TopicPhase 1NCT03212586
BAY 1902607: Single Dose Escalation, Safety and Tolerability, Pharmacokinetics, Bioavailability, Food Effect
A Phase 1 study testing BAY1902607 in people with Clinical Trials, Phase I as Topic, run by Bayer at 1 site in Germany.
Trial summary
This study is a first-in-man study that will investigate the safety, tolerability and pharmacokinetics of ascending single doses of BAY1902607 using a placebo controlled, randomized, single center design. 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
- Clinical Trials, Phase I as Topic
- What is being tested?
- BAY1902607
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- 18 Jul 2017to 27 Jul 2018
- 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 subjects.
- Age: 18 to 45 years (inclusive) .
- Body mass index (BMI) : ≥18 and ≤30 kg/m^2.
- Race: White.
Who cannot join
- Any findings from the medical examination (including medical history, physical examination, vital signs, laboratory tests and ECG) deviating from normal and deemed by the investigator to be of clinical relevance.
- Relevant diseases within the 4 weeks before the first drug administration.
- Febrile illness within the week before the first taste test is conducted.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Placebo-controlled, Double-blind, Parallel-group Study to Investigate the Safety, Tolerability and Pharmacokinetics of Increasing Single Oral Doses of BAY1902607 Including the Relative Bioavailability Between Different Pharmaceutical Formulations and the Effect of Food on the Pharmacokinetics of BAY1902607 in Healthy Men
This study is a first-in-man study that will investigate the safety, tolerability and pharmacokinetics of ascending single doses of BAY1902607 using a placebo controlled, randomized, single center design. In addition the influence of food on the pharmacokinetics of BAY1902607 and the bioavailability between different pharmaceutical formulations will be investigated
- Conditions
- Clinical Trials, Phase I as Topic
- Being tested
- BAY1902607, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY1902607Drug
Escalating doses of BAY1902607; single dose administration; different dosage forms (redosing of BAY1902607 at dose group 4 with different formulations; redosing of BAY1902607 solid formulation at dose group 4 together with food)
PlaceboDrug
Escalating doses of Placebo; single dose administration; different dosage forms (redosing of Placebo at dose group 4 with different formulations; redosing of Placebo solid formulation at dose group 4 together with food)
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation BAY1902607 | Experimental | Dose 1 to 9 of BAY1902607 Receives: Drug: BAY1902607 |
| Dose escalation Placebo | Placebo comparator | Dose 1 to 9 of matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with treatment-emergent adverse events
AE is any untoward medical occurrence (i.e. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a patient or clinical investigation subject after providing written informed consent for participation in the study. AEs (except for those in the 60 mg dose group) were considered to be treatment-emergent if they had started or worsened within the interval from first study drug administration until the follow-up visit. For the 60 mg dose group, AEs were considered to be TEAEs if they had started or worsened within one of the following intervals: 1) from first administration of study medication in treatment period 1 to 15 days thereafter, 2) from second administration of study medication in treatment period 2 to 15 days thereafter, 3) from third administration of study medication in treatment period 3 to follow-up visit.
Measured: Up to 11 weeks
Number of subjects with severity of treatment-emergent adverse events
AEs were considered to be TEAEs if they had started or worsened within the interval from first study drug administration until the follow-up visit (except for the 60 mg dose group: from first study drug administration in treatment period 1 to 15 days thereafter; from second study drug administration in treatment period 2 to 15 days thereafter; from third study drug administration in treatment period 3 to follow-up visit). Classification of the intensity: Mild (usually transient and might have required only minimal treatment or therapeutic intervention, did not generally interfere with usual activities of daily living), Moderate (usually alleviated with additional specific therapeutic intervention, interfered with usual activities of daily living, causing discomfort but posed no significant or permanent risk of harm to the research subject), Severe (required intensive therapeutic intervention, interrupted usual activities of daily living, or significantly affected clinical status).
Measured: Up to 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start18 Jul 2017
- Primary completion3 May 2018
- Study completion27 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Trials, Phase I as TopicStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212586
- Sponsor's protocol ID
- 18922
- Other IDs
- 2017-000978-11, 2017
- Status last verified
- May 2019
- First submitted
- 7 Jul 2017
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-controlled, Double-blind, Parallel-group Study to Investigate the Safety, Tolerability and Pharmacokinetics of Increasing Single Oral Doses of BAY1902607 Including the Relative Bioavailability Between Different Pharmaceutical Formulations and the Effect of Food on the Pharmacokinetics of BAY1902607 in Healthy Men
- ClinicalTrials.gov ID
- NCT03212586
- Acronym / sponsor ID
- 18922
- Conditions
- Clinical Trials, Phase I as Topic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2017 (actual)
- Primary completion
- 3 May 2018 (actual)
- Study completion
- 27 Jul 2018 (actual)
- First posted
- 11 Jul 2017 (actual)
- 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.
This study is a first-in-man study that will investigate the safety, tolerability and pharmacokinetics of ascending single doses of BAY1902607 using a placebo controlled, randomized, single center design. In addition the influence of food on the pharmacokinetics of BAY1902607 and the bioavailability between different pharmaceutical formulations will be investigated
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose escalation BAY1902607 | Experimental | Drug: BAY1902607Dose 1 to 9 of BAY1902607 |
| Dose escalation Placebo | Placebo comparator | Drug: PlaceboDose 1 to 9 of matching placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subjects.
- Age: 18 to 45 years (inclusive) .
- Body mass index (BMI) : ≥18 and ≤30 kg/m^2.
- Race: White.
Key exclusion criteria (3 listed)
- Any findings from the medical examination (including medical history, physical examination, vital signs, laboratory tests and ECG) deviating from normal and deemed by the investigator to be of clinical relevance.
- Relevant diseases within the 4 weeks before the first drug administration.
- Febrile illness within the week before the first taste test is conducted.
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 |
|---|---|---|
| BAY1902607Escalating doses of BAY1902607; single dose administration; different dosage forms (redosing of BAY1902607 at dose group 4 with different formulations; redosing of BAY1902607 solid formulation at dose group 4 together with food) | Drug | Dose escalation BAY1902607 |
| PlaceboEscalating doses of Placebo; single dose administration; different dosage forms (redosing of Placebo at dose group 4 with different formulations; redosing of Placebo solid formulation at dose group 4 together with food) | Drug | Dose escalation Placebo |
Primary outcome
Number of subjects with treatment-emergent adverse events
Time frame: Up to 11 weeks
AE is any untoward medical occurrence (i.e. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a patient or clinical investigation subject after providing written informed consent for participation in the study. AEs (except for those in the 60 mg dose group) were considered to be treatment-emergent if they had started or worsened within the interval from first study drug administration until the follow-up visit. For the 60 mg dose group, AEs were considered to be TEAEs if they had started or worsened within one of the following intervals: 1) from first administration of study medication in treatment period 1 to 15 days thereafter, 2) from second administration of study medication in treatment period 2 to 15 days thereafter, 3) from third administration of study medication in treatment period 3 to follow-up visit.
Number of subjects with severity of treatment-emergent adverse events
Time frame: Up to 11 weeks
AEs were considered to be TEAEs if they had started or worsened within the interval from first study drug administration until the follow-up visit (except for the 60 mg dose group: from first study drug administration in treatment period 1 to 15 days thereafter; from second study drug administration in treatment period 2 to 15 days thereafter; from third study drug administration in treatment period 3 to follow-up visit). Classification of the intensity: Mild (usually transient and might have required only minimal treatment or therapeutic intervention, did not generally interfere with usual activities of daily living), Moderate (usually alleviated with additional specific therapeutic intervention, interfered with usual activities of daily living, causing discomfort but posed no significant or permanent risk of harm to the research subject), Severe (required intensive therapeutic intervention, interrupted usual activities of daily living, or significantly affected clinical status).
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 14 May 2019.
- Click here to find information about studies related to Bayer Healthcare products conducted in Europe.Link provided by the sponsor.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 BAY1902607 in people with Clinical Trials, Phase I as Topic, 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 3 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 14 May 2019. 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?
Number of subjects with treatment-emergent adverse events (time frame: Up to 11 weeks). 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 14 May 2019.