A Study to Assess the Effects of BPN14770 on Rosuvastatin

NCT07011992 — Phase 1, Completed, 12 participants, Shionogi

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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

RegistryNCT07011992
StatusCompleted
PhasePhase 1
Study typeInterventional; na, single group, masking: none, treatment
Enrollment12 (Actual)
SponsorShionogi (Industry)
ConditionsHealthy Participants
InterventionsRosuvastatin, BPN14770 (Drug)
Datesstart 2025-07-18, primary completion 2025-07-31, completion 2025-08-07, first posted 2025-06-10, last updated 2025-08-14
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Healthy Participants All trials of Rosuvastatin All trials of BPN14770

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
BPN14770ExperimentalDrug: Rosuvastatin; Drug: BPN14770Participants will receive rosuvastatin and BPN14770.
  • Rosuvastatin (Drug): Oral tablet
  • BPN14770 (Drug), also known as Zatolmilast: Oral capsule

+Outcome measures

Primary outcomes

  • Maximum Plasma Concentration (Cmax) of Rosuvastatin [Days 1 and 11 (pre-dose, up to 72 hours post-dose)]
  • Time to Maximum Plasma Concentration (Tmax) of Rosuvastatin [Days 1 and 11 (pre-dose, up to 72 hours post-dose)]

Secondary outcomes

  • Cmax of BPN14770 [Day 11 (pre-dose, up to 72 hours post-dose)]
  • Tmax of BPN14770 [Day 11 (pre-dose, up to 72 hours post-dose)]
  • Cmax of Coproporphyrin I [Days 1 and 11 (pre-dose, up to 72 hours post-dose)]
  • Tmax of Coproporphyrin I [Days 1 and 11 (pre-dose, up to 72 hours post-dose)]
  • Number of Participants Experiencing Treatment-emergent Adverse Events [Day 1 through Day 21]

+Eligibility

Sex: All, ages: 18 Years to 55 Years, accepts healthy volunteers

Key Inclusion Criteria:

* 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:

* 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

+Locations (1)

FacilityCityCountryStatus
ICON Clinical ResearchLenexa, KansasUnited States