Healthy Volunteer
Conditions
Keywords
Healthy Volunteer
Brief summary
A Study to Assess Adverse Events, Tolerability and How a Single Oral Dose of Nacresertib Moves Through the Body In Healthy Adult Japanese Participants
Interventions
DRUGNacresertib
Oral tablet
DRUGPlacebo for Nacresertib
Oral tablet
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy Japanese male or female; 18 to 65 years of age at the time of screening. * Japanese participant must be first-or second-generation Japanese of full Japanese parentage. First-generation participants will have been born in Japan to two parents and four grandparents also born in Japan of full Japanese descent. Second-generation participants born outside of Japan must have two parents and four grandparents born in Japan of full Japanese descent. * BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenth decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
Exclusion criteria
* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness. * History of any clinically significant sensitivity or allergy to any medication or food. * History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption \[e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.\].
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Nacresertib | Up to 9 Days | Cmax of Nacresertib |
| Time to Cmax (Tmax) of Nacresertib | Up to 9 Days | Tmax of Nacresertib |
| Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of Nacresertib | Up to 9 Days | AUCt of Nacresertib |
| AUC From Time 0 to the Time Infinity (AUCinf) of Nacresertib | Up to 9 Days | AUCinf of Nacresertib |
| Terminal Phase Elimination Rate Constant (Beta) of Nacresertib | Up to 9 Days | Beta of Nacresertib |
| Terminal Phase Elimination Half-Life (t1/2) of Nacresertib | Up to 9 Days | t1/2 of Nacresertib |
| Number of Participants Experiencing Adverse Events (AEs) | Up to 42 Days | Any untoward medical occurrence in a participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment |
Countries
United States
Contacts
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed