Healthy VolunteersPhase 1NCT06078202
A Study to Assess the Relative Bioavailability of Three Immediate-Release Tablet Formulations of ABBV-903 in Healthy Adult Volunteers
A Phase 1 study testing ABBV-903 in people with Healthy Volunteers, run by AbbVie at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the relative bioavailability of three immediate-release table formulations of ABBV-903 under fasting conditions in healthy volunteers, and to evaluate the effect of food on the pharmacokinetics of three immediate-release table formulations of ABBV-903. 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?
- ABBV-903
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2024to 31 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Body Mass Index (BMI) is >= 18.0 to <= 32.0 kg/m2 after rounding to the tenths decimal, at screening and upon initial confinement.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).
Who cannot join
- History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
- History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, 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: Assessment of the Relative Bioavailability of Three Immediate-Release Tablet Formulations of ABBV-903 in Healthy Volunteers
The purpose of this study is to evaluate the relative bioavailability of three immediate-release table formulations of ABBV-903 under fasting conditions in healthy volunteers, and to evaluate the effect of food on the pharmacokinetics of three immediate-release table formulations of ABBV-903.
- Conditions
- Healthy Volunteers
- Being tested
- ABBV-903
- Keywords
- ABBV-903, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-903Drug
Tablet; oral
| Study group | Role | What they receive |
|---|---|---|
| Part 1, Sequence A | Experimental | Participants will receive 1 dose of ABBV-903. Receives: Drug: ABBV-903 |
| Part 1, Sequence B | Experimental | Participants will receive 1 dose of ABBV-903. Receives: Drug: ABBV-903 |
| Part 1, Sequence C | Experimental | Participants will receive 1 dose of ABBV-903. Receives: Drug: ABBV-903 |
| Part 2, Sequence A | Experimental | Participants will receive 1 dose of ABBV-903. Receives: Drug: ABBV-903 |
| Part 2, Sequence B | Experimental | Participants will receive 1 dose of ABBV-903. Receives: Drug: ABBV-903 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of ABBV-903
Cmax of ABBV-903 will be assessed.
Measured: From 0 - 96 hours
Time to Cmax (Tmax) of ABBV-903
Tmax of ABBV-903 will be assessed.
Measured: From 0 - 96 hours
Apparent Terminal Phase Elimination Constant (BETA) of ABBV-903
BETA of ABBV-903 will be assessed.
Measured: From 0 - 96 hours
Terminal Phase Elimination Half-life (t1/2) of ABBV-903
Terminal phase elimination half-life (t1/2) of ABBV-903 will be assessed.
Measured: From 0 - 96 hours
Area Under the Plasma Concentration-time Curve from Time 0 until 24 Hours after Dosing (AUC0-24) of ABBV-903
AUC0-24 of ABBV-903 will be assessed.
Measured: From 0 - 96 hours
AUC from Time 0 until the Last Measurable Concentration (AUCt) of ABBV-903
AUCt of ABBV-903 will be assessed.
Measured: From 0 - 96 hours
AUC from Time 0 to Infinite Time (AUCinf) of ABBV-903
AUCinf of ABBV-903 will be assessed.
Measured: From 0 - 96 hours
Number of Participants with Adverse Events
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.
Measured: Up to 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start1 Dec 2024 (estimated)
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Why it stopped: Strategic considerations
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT06078202
- Sponsor's protocol ID
- M24-231
- Status last verified
- Sep 2024
- First submitted
- 5 Oct 2023
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Relative Bioavailability of Three Immediate-Release Tablet Formulations of ABBV-903 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06078202
- Acronym / sponsor ID
- M24-231
- Conditions
- Healthy Volunteers
- Keywords
- ABBV-903, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Strategic considerations
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the relative bioavailability of three immediate-release table formulations of ABBV-903 under fasting conditions in healthy volunteers, and to evaluate the effect of food on the pharmacokinetics of three immediate-release table formulations of ABBV-903.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1, Sequence A | Experimental | Drug: ABBV-903Participants will receive 1 dose of ABBV-903. |
| Part 1, Sequence B | Experimental | Drug: ABBV-903Participants will receive 1 dose of ABBV-903. |
| Part 1, Sequence C | Experimental | Drug: ABBV-903Participants will receive 1 dose of ABBV-903. |
| Part 2, Sequence A | Experimental | Drug: ABBV-903Participants will receive 1 dose of ABBV-903. |
| Part 2, Sequence B | Experimental | Drug: ABBV-903Participants will receive 1 dose of ABBV-903. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body Mass Index (BMI) is >= 18.0 to <= 32.0 kg/m2 after rounding to the tenths decimal, at screening and upon initial confinement.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).
Key exclusion criteria (2 listed)
- History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
- History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABBV-903Tablet; oral | Drug | Part 1, Sequence A, Part 1, Sequence B, Part 1, Sequence C, Part 2, Sequence A, Part 2, Sequence B |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of ABBV-903
Time frame: From 0 - 96 hours
Cmax of ABBV-903 will be assessed.
Time to Cmax (Tmax) of ABBV-903
Time frame: From 0 - 96 hours
Tmax of ABBV-903 will be assessed.
Apparent Terminal Phase Elimination Constant (BETA) of ABBV-903
Time frame: From 0 - 96 hours
BETA of ABBV-903 will be assessed.
Terminal Phase Elimination Half-life (t1/2) of ABBV-903
Time frame: From 0 - 96 hours
Terminal phase elimination half-life (t1/2) of ABBV-903 will be assessed.
Area Under the Plasma Concentration-time Curve from Time 0 until 24 Hours after Dosing (AUC0-24) of ABBV-903
Time frame: From 0 - 96 hours
AUC0-24 of ABBV-903 will be assessed.
AUC from Time 0 until the Last Measurable Concentration (AUCt) of ABBV-903
Time frame: From 0 - 96 hours
AUCt of ABBV-903 will be assessed.
AUC from Time 0 to Infinite Time (AUCinf) of ABBV-903
Time frame: From 0 - 96 hours
AUCinf of ABBV-903 will be assessed.
Number of Participants with Adverse Events
Time frame: Up to 42 days
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABBV-903 in people with Healthy Volunteers, run by AbbVie at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Plasma Concentration (Cmax) of ABBV-903 (time frame: From 0 - 96 hours). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.