Healthy Volunteers
Conditions
Brief summary
The objectives for this 2 Part study are to assess the safety, tolerability, and pharmacokinetics following single ascending oral doses of nacresertib in healthy adult participants (Part 1) and to assess the safety, tolerability, and pharmacokinetics following multiple ascending oral doses in healthy adult participants (Part 2).
Interventions
DRUGnacresertib
Oral
DRUGPlacebo
Oral
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
\-- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG.
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 Day 19 | Cmax of nacresertib |
| Time to Cmax (Tmax) of nacresertib | Up to Day 19 | 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 Day 19 | AUCt of nacresertib |
| AUC From Time 0 to the Time Infinity (AUCinf) of nacresertib | Up to Day 19 | AUCinf of nacresertib |
| Part 2 Only: Area under the Plasma Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUCtau) of nacresertib | Up to Day 14 | AUCtau of nacresertib |
| Terminal Phase Elimination Rate Constant (Beta) of nacresertib | Up to Day 19 | Beta of nacresertib |
| Terminal Phase Elimination Half-Life (t1/2) of nacresertib | Up to Day 19 | t1/2 of nacresertib |
| Dose Normalized Cmax | Up to Day 19 | Dose Normalized Cmax |
| Dose Normalized AUCs | Up to Day 19 | Dose Normalized AUCs |
| Number of Participants Experiencing Adverse Events (AEs) | 74 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