Healthy VolunteersPhase 1NCT06414798
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABBV-1088 Oral Dose in Healthy Adult Participants.
A Phase 1 study testing Drug: ABBV-1088 in people with Healthy Volunteers, run by AbbVie at 1 site in United States.
Trial summary
This study will assess the single dose safety, tolerability and pharmacokinetic properties of ABBV-1088 in healthy adult participants 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?
- Drug: ABBV-1088
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2024to 8 Feb 2025
- 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
- BMI is ≥ 18.0 to ≤ 32.0 kg/m^2 after rounding to the tenths decimal at screening.
- 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 cardiac disease, including congenital structural/conduction abnormalities, cardiomyopathy, myocardial infarction, cardiac arrhythmia.
- History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption [e.g., Crohn's disease, chronic GERD, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.].
- History of suicidal ideation within one year prior to study drug administration as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the C-SSRS completed at Screening, or any history of suicide attempts within the last two years.
- History of any clinically significant neurological, respiratory (except mild asthma as a child), endocrine, metabolic, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A First-in-Human Single Ascending Dose, Mass Balance, and Food Effect Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABBV-1088 in Healthy Adult Subjects
This study will assess the single dose safety, tolerability and pharmacokinetic properties of ABBV-1088 in healthy adult participants
- Conditions
- Healthy Volunteers
- Being tested
- Drug: ABBV-1088, Drug: Placebo for ABBV-1088
- Keywords
- Healthy Volunteers, ABBV-1088
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: ABBV-1088Drug
- Oral Capsule
Drug: Placebo for ABBV-1088Drug
- Oral Capsule
| Study group | Role | What they receive |
|---|---|---|
| Group 1- ABBV-1088 Dose A | Experimental | Participants will receive single dose of ABBV-1088 dose A on day 1 Receives: Drug: Drug: ABBV-1088 |
| Group 1- Placebo | Experimental | Participants will receive single dose of placebo day 1 Receives: Drug: Drug: Placebo for ABBV-1088 |
| Group 2- ABBV-1088 Dose B | Experimental | Participants will receive single dose of ABBV-1088 dose B on day 1 Receives: Drug: Drug: ABBV-1088 |
| Group 2- Placebo | Experimental | Participants will receive single dose of placebo day 1 Receives: Drug: Drug: Placebo for ABBV-1088 |
| Group 3- ABBV-1088 Dose C | Experimental | Participants will receive single dose of ABBV-1088 dose C on day 1 Receives: Drug: Drug: ABBV-1088 |
| Group 3- Placebo | Experimental | Participants will receive single dose of placebo day 1 Receives: Drug: Drug: Placebo for ABBV-1088 |
| Group 4- ABBV-1088 Dose D | Experimental | Participants will receive single dose of ABBV-1088 dose D on day 1 Receives: Drug: Drug: ABBV-1088 |
| Group 4- Placebo | Experimental | Participants will receive single dose of placebo day 1 Receives: Drug: Drug: Placebo for ABBV-1088 |
| Group 5- ABBV-1088 Dose E | Experimental | Participants will receive single dose of ABBV-1088 dose E on day 1 Receives: Drug: Drug: ABBV-1088 |
| Group 5- Placebo | Experimental | Participants will receive single dose of placebo day 1 Receives: Drug: Drug: Placebo for ABBV-1088 |
| Group 6- ABBV-1088 Dose F | Experimental | Participants will receive single dose of ABBV-1088 dose F on day 1 Receives: Drug: Drug: ABBV-1088 |
| Group 6- Placebo | Experimental | Participants will receive single dose of placebo day 1 Receives: Drug: Drug: Placebo for ABBV-1088 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) of ABBV-1088
Cmax of ABBV-1088
Measured: Up to approximately 11 days
Time to Cmax (Tmax) of ABBV-1088
Tmax of ABBV-1088
Measured: Up to approximately 11 days
Terminal Phase Elimination Rate Constant (Beta) of ABBV-1088
Terminal phase elimination rate constant (beta) of ABBV-1088
Measured: Up to approximately 11 days
Terminal Phase Elimination Half-Life (t1/2) of ABBV-1088
Terminal phase elimination half-life of ABBV-1088
Measured: Up to approximately 11 days
Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-1088
AUCt of ABBV-1088
Measured: Up to approximately 11 days
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-1088
AUCinf of ABBV-1088
Measured: Up to approximately 11 days
Number of Participants With Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study
Measured: Up to Day 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start13 May 2024
- Primary completion8 Feb 2025
- Study completion8 Feb 2025
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, Investigator, Outcomes assessor
- Enrolment
- 60 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
- NCT06414798
- Sponsor's protocol ID
- M24-929
- Status last verified
- Feb 2025
- First submitted
- 10 May 2024
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No