Healthy Participants
Conditions
Keywords
BPN14770, Rosuvastatin, Pharmacokinetics
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.
Interventions
DRUGRosuvastatin
Oral tablet
DRUGBPN14770
Oral capsule
Sponsors
Shionogi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Cmax of Coproporphyrin I | Days 1 and 11 (pre-dose, up to 72 hours post-dose) |
| Cmax of BPN14770 | Day 11 (pre-dose, up to 72 hours post-dose) |
| Number of Participants Experiencing Treatment-emergent Adverse Events | Day 1 through Day 21 |
| Tmax of Coproporphyrin I | Days 1 and 11 (pre-dose, up to 72 hours post-dose) |
| Tmax of BPN14770 | Day 11 (pre-dose, up to 72 hours post-dose) |
Countries
United States
Outcome results
None listed