Clinical trial NCT07011992: A Study to Assess the Effects of BPN14770 on Rosuvastatin
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy Participants
Keywords: BPN14770
Rosuvastatin
Pharmacokinetics
Lead sponsor: Shionogi Inc.
Sponsor class: INDUSTRY
First posted: 2025-06-10
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax) of Rosuvastatin
timeFrame: Days 1 and 11 (pre-dose, up to 72 hours post-dose)
measure: Time to Maximum Plasma Concentration (Tmax) of Rosuvastatin
timeFrame: Days 1 and 11 (pre-dose, up to 72 hours post-dose)
Secondary outcomes:
measure: Cmax of BPN14770
timeFrame: Day 11 (pre-dose, up to 72 hours post-dose)
measure: Tmax of BPN14770
timeFrame: Day 11 (pre-dose, up to 72 hours post-dose)
measure: Cmax of Coproporphyrin I
timeFrame: Days 1 and 11 (pre-dose, up to 72 hours post-dose)
measure: Tmax of Coproporphyrin I
timeFrame: Days 1 and 11 (pre-dose, up to 72 hours post-dose)
measure: Number of Participants Experiencing Treatment-emergent Adverse Events
timeFrame: Day 1 through Day 21
Other outcomes:
Locations:
Study officials:
References: