NCT07600762CompletedPhase 1
A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Nacresertib in Healthy Adult Japanese Subjects
AbbVie1 site in 1 country12 target enrollmentStarted: April 21, 2026Last updated:
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 12
- Locations
- 1
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.].
Arms & Interventions
Nacresertib
Experimental
Participants will receive a single dose of Nacresertib
Intervention: Nacresertib (Drug)
Placebo for Nacresertib
Placebo Comparator
Participants will receive a single dose of Placebo for Nacresertib
Intervention: Placebo for Nacresertib (Drug)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Recruiting
Phase 1
A Study of ONO-3310 in Healthy Adult Male Subjects and Chronic Kidney Disease Patients With Type 2 Diabetes MellitusChronic Kidney DiseaseNCT07619157Ono Pharmaceutical Co., Ltd.120
Recruiting
Phase 1
A Study of MG2512 Injection in Participants With Advanced Solid TumorsNCT07348653Shanghai Mabgen Biopharmaceutical Technology Co., Ltd.116
Completed
Phase 1
A Phase I Study to Evaluate the Safety and Tolerability of JL15003 Injection in Patients With Recurrent GlioblastomaRecurrent Glioblastoma Multiforme(GBM)NCT07497373Jecho Biopharmaceuticals Co., Ltd.17
Not yet recruiting
Phase 1
A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Gastrodin Injection in Healthy Chinese SubjectsDeliriumNCT07422142Kunming Pharmaceuticals, Inc.54
Recruiting
Phase 1
Phase I Study of CPD704 Inhalation Suspension in Healthy SubjectsNCT07301203Beijing Tide Pharmaceutical Co., Ltd90