Healthy ParticipantsPhase 1NCT07011992
A Study to Assess the Effects of BPN14770 on Rosuvastatin
A Phase 1 study testing Rosuvastatin and BPN14770 in people with Healthy Participants, run by Shionogi at 1 site in United States.
Trial summary
The primary objective of this study is to investigate the effects of BPN14770 on the pharmacokinetics of the breast cancer resistance protein and organic anion transporting polypeptide 1B1 substrate rosuvastatin in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Rosuvastatin and BPN14770
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2025to 7 Aug 2025
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Overtly healthy as determined by medical evaluation including medical history, medical examination, laboratory tests, vital sign measurements, and 12-lead electrocardiogram at screening and on admission or participants whose laboratory values exceed the institutional reference range but deemed not clinically significant by the investigator in consideration of safety
- Body mass index ≥18.5 and <32.0 kilograms/meter squared
- All female participants must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations)
Who cannot join
- Presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological, or ophthalmological (that is, increased intraocular pressure) disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data per the investigator's assessment
- Known history of allergic reaction to multiple medications and/or severe allergic reaction to any food or environmental allergens
- Prior use of rosuvastatin that was discontinued for tolerability or adverse events
- Received ≥4 types of investigational study interventions within 12 months prior to administration of study intervention
- Positive drug or alcohol screen test result at screening or upon admission
- Use of cannabis (medical or recreational), tobacco, or nicotine-containing products (including e-cigarettes, pipe tobacco, cigar, chewing tobacco, nicotine patch, and nicotine gum) within 6 months prior to admission
- Note: Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, 1-Sequence Crossover, Drug-drug Interaction Study to Assess the Effect of Repeated Doses of BPN14770 on the Pharmacokinetics of Rosuvastatin in Healthy Adult Participants
The primary objective of this study is to investigate the effects of BPN14770 on the pharmacokinetics of the breast cancer resistance protein and organic anion transporting polypeptide 1B1 substrate rosuvastatin in healthy adults.
- Conditions
- Healthy Participants
- Being tested
- Rosuvastatin, BPN14770
- Keywords
- BPN14770, Rosuvastatin, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Oral tablet
BPN14770Drug
Also called Zatolmilast
Oral capsule
| Study group | Role | What they receive |
|---|---|---|
| BPN14770 | Experimental | Participants will receive rosuvastatin and BPN14770. Receives: Drug: Rosuvastatin; Drug: BPN14770 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) of Rosuvastatin
Measured: Days 1 and 11 (pre-dose, up to 72 hours post-dose)
Time to Maximum Plasma Concentration (Tmax) of Rosuvastatin
Measured: Days 1 and 11 (pre-dose, up to 72 hours post-dose)
Secondary outcomes (5)
Cmax of BPN14770
Measured: Day 11 (pre-dose, up to 72 hours post-dose)
Tmax of BPN14770
Measured: Day 11 (pre-dose, up to 72 hours post-dose)
Cmax of Coproporphyrin I
Measured: Days 1 and 11 (pre-dose, up to 72 hours post-dose)
Tmax of Coproporphyrin I
Measured: Days 1 and 11 (pre-dose, up to 72 hours post-dose)
Number of Participants Experiencing Treatment-emergent Adverse Events
Measured: Day 1 through Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start18 Jul 2025
- Primary completion31 Jul 2025
- Study completion7 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by ShionogiThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shionogi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011992
- Sponsor's protocol ID
- 2413A4111
- Status last verified
- Aug 2025
- First submitted
- 2 Jun 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, 1-Sequence Crossover, Drug-drug Interaction Study to Assess the Effect of Repeated Doses of BPN14770 on the Pharmacokinetics of Rosuvastatin in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07011992
- Acronym / sponsor ID
- 2413A4111
- Conditions
- Healthy Participants
- Keywords
- BPN14770, Rosuvastatin, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- ShionogiIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2025 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 7 Aug 2025 (actual)
- First posted
- 10 Jun 2025 (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.
The primary objective of this study is to investigate the effects of BPN14770 on the pharmacokinetics of the breast cancer resistance protein and organic anion transporting polypeptide 1B1 substrate rosuvastatin in healthy adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BPN14770 | Experimental | Drug: Rosuvastatin, Drug: BPN14770Participants will receive rosuvastatin and BPN14770. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Overtly healthy as determined by medical evaluation including medical history, medical examination, laboratory tests, vital sign measurements, and 12-lead electrocardiogram at screening and on admission or participants whose laboratory values exceed the institutional reference range but deemed not clinically significant by the investigator in consideration of safety
- Body mass index ≥18.5 and <32.0 kilograms/meter squared
- All female participants must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations)
Key exclusion criteria (7 listed)
- Presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological, or ophthalmological (that is, increased intraocular pressure) disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data per the investigator's assessment
- Known history of allergic reaction to multiple medications and/or severe allergic reaction to any food or environmental allergens
- Prior use of rosuvastatin that was discontinued for tolerability or adverse events
- Received ≥4 types of investigational study interventions within 12 months prior to administration of study intervention
- Positive drug or alcohol screen test result at screening or upon admission
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 |
|---|---|---|
| RosuvastatinOral tablet | Drug | BPN14770 |
| BPN14770Also: ZatolmilastOral capsule | Drug | BPN14770 |
Primary outcome
Maximum Plasma Concentration (Cmax) of Rosuvastatin
Time frame: Days 1 and 11 (pre-dose, up to 72 hours post-dose)
Time to Maximum Plasma Concentration (Tmax) of Rosuvastatin
Time frame: Days 1 and 11 (pre-dose, up to 72 hours post-dose)
5 secondary outcomes
Cmax of BPN14770
Time frame: Day 11 (pre-dose, up to 72 hours post-dose)
Tmax of BPN14770
Time frame: Day 11 (pre-dose, up to 72 hours post-dose)
Cmax of Coproporphyrin I
Time frame: Days 1 and 11 (pre-dose, up to 72 hours post-dose)
Tmax of Coproporphyrin I
Time frame: Days 1 and 11 (pre-dose, up to 72 hours post-dose)
Number of Participants Experiencing Treatment-emergent Adverse Events
Time frame: Day 1 through Day 21
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 Aug 2025.
- Individual participant dataSharing planned: No
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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.
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 Rosuvastatin and BPN14770 in people with Healthy Participants, run by Shionogi at 1 site in United States.
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 3 inclusion and 7 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 Aug 2025. 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 United States. 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?
Maximum Plasma Concentration (Cmax) of Rosuvastatin (time frame: Days 1 and 11 (pre-dose, up to 72 hours post-dose)). 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 Aug 2025.