Healthy VolunteersPhase 1NCT07566130
A Study to Assess Adverse Events, Tolerability and How Single and Ascending Oral Doses of Nacresertib Move Through the Body In Healthy Adult Participants
A Phase 1 study testing nacresertib in people with Healthy Volunteers, run by AbbVie at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- nacresertib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2025to 7 May 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -- 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.
Who cannot join
- 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.]
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics Following Single and Multiple Ascending Oral Doses of Nacresertib in Healthy Adult Subjects
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).
- Conditions
- Healthy Volunteers
- Being tested
- nacresertib, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nacresertibDrug
Oral
PlaceboDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose A | Experimental | Participants will receive a single dose of nacresertib or Placebo Receives: Drug: nacresertib; Drug: Placebo |
| Part 1: Dose B | Experimental | Participants will receive a single dose of nacresertib or Placebo Receives: Drug: nacresertib; Drug: Placebo |
| Part 1: Dose C | Experimental | Participants will receive a single dose of nacresertib or Placebo Receives: Drug: nacresertib; Drug: Placebo |
| Part 1: Dose D | Experimental | Participants will receive a single dose of nacresertib or Placebo Receives: Drug: nacresertib; Drug: Placebo |
| Part 1: Dose E | Experimental | Participants will receive a single dose of nacresertib or Placebo Receives: Drug: nacresertib; Drug: Placebo |
| Part 2: Dose F | Experimental | Participants will receive multiple doses of nacresertib or Placebo Receives: Drug: nacresertib; Drug: Placebo |
| Part 2: Dose G | Experimental | Participants will receive multiple doses of nacresertib or Placebo Receives: Drug: nacresertib; Drug: Placebo |
| Part 2: Dose H | Experimental | Participants will receive multiple doses of nacresertib or Placebo Receives: Drug: nacresertib; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of nacresertib
Cmax of nacresertib
Measured: Up to Day 19
Time to Cmax (Tmax) of nacresertib
Tmax of nacresertib
Measured: Up to Day 19
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of nacresertib
AUCt of nacresertib
Measured: Up to Day 19
AUC From Time 0 to the Time Infinity (AUCinf) of nacresertib
AUCinf of nacresertib
Measured: Up to Day 19
Part 2 Only: Area under the Plasma Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUCtau) of nacresertib
AUCtau of nacresertib
Measured: Up to Day 14
Terminal Phase Elimination Rate Constant (Beta) of nacresertib
Beta of nacresertib
Measured: Up to Day 19
Terminal Phase Elimination Half-Life (t1/2) of nacresertib
t1/2 of nacresertib
Measured: Up to Day 19
Dose Normalized Cmax
Dose Normalized Cmax
Measured: Up to Day 19
Dose Normalized AUCs
Dose Normalized AUCs
Measured: Up to Day 19
Number of Participants Experiencing Adverse Events (AEs)
Any untoward medical occurrence in a participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment
Measured: 74 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start18 Apr 2025
- Primary completion7 May 2026
- Study completion7 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07566130
- Sponsor's protocol ID
- M25-471
- Status last verified
- Jun 2026
- First submitted
- 29 Apr 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No