Healthy VolunteerPhase 1NCT05836506
A Study to Assess the Relative Bioavailability of Immediate Release Formulations of ABBV-903 in Healthy Adult Participants
A Phase 1 study testing ABBV-903 Tablet Form 1 and ABBV-903 Tablet Form 2 in people with Healthy Volunteer, run by AbbVie at 1 site in United States.
Trial summary
The main objective of this study is to assess the relative bioavailability and pharmacokinetics of ABBV-903 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 Volunteer
- What is being tested?
- ABBV-903 Tablet Form 1 and ABBV-903 Tablet Form 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2023to 20 Jun 2023
- 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
- BMI is ≥ 18.0 to ≤ 32 kg/m2 after rounding to the tenth.
- Negative test result for SARS-CoV-2 infection at screening visit 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 ECG.
Who cannot join
- 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.
- History of diseases aggravated or triggered by ultraviolet radiation and no history of abnormal reaction photosensitivity or photoallergy to sunlight, or artificial source of intense light, especially ultraviolet light.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Relative Bioavailability of Immediate Release Formulations of ABBV-903 in Healthy Volunteers
The main objective of this study is to assess the relative bioavailability and pharmacokinetics of ABBV-903 in healthy adult participants.
- Conditions
- Healthy Volunteer
- Being tested
- ABBV-903 Tablet Form 1, ABBV-903 Tablet Form 2
- Keywords
- ABBV-903, Healthy Volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-903 Tablet Form 1Drug
Oral Tablets
ABBV-903 Tablet Form 2Drug
Oral Tablets
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Sequence A | Experimental | In Period 1 on Day 1, participants will receive ABBV-903 Tablet Form 1 after fasting. In Period 2 on Day 1, participants will receive ABBV-903 Tablet Form 2 after fasting. Lastly, in Period 3 on Day 1, participants will receive ABBV-903 Tablet Form 1 after a high fat meal. Participants will be followed up for 30 days. Receives: Drug: ABBV-903 Tablet Form 1; Drug: ABBV-903 Tablet Form 2 |
| Part 1: Sequence B | Experimental | In Period 1 on Day 1, participants will receive ABBV-903 Tablet Form 2 after fasting. In Period 2 on Day 1, participants will receive ABBV-903 Tablet Form 1 after fasting. Lastly, in Period 3 on Day 1, participants will receive ABBV-903 Tablet Form 1 after fasting. Participants will be followed up for 30 days. Receives: Drug: ABBV-903 Tablet Form 1; Drug: ABBV-903 Tablet Form 2 |
| Part 2: Sequence A | Experimental | In Period 1 on Day 1, participants will receive ABBV-903 Tablet Form 1 after fasting. In Period 2 on Day 1, participants will receive ABBV-903 Tablet Form 2 after fasting. Lastly, in Period 3 on Day 1, participants will receive ABBV-903 Tablet Form 2 after a high fat meal. Participants will be followed up for 30 days. Receives: Drug: ABBV-903 Tablet Form 1; Drug: ABBV-903 Tablet Form 2 |
| Part 2: Sequence B | Experimental | In Period 1 on Day 1, participants will receive ABBV-903 Tablet Form 2 after fasting. In Period 2 on Day 1, participants will receive ABBV-903 Tablet Form 1 after fasting. Lastly, in Period 3 on Day 1, participants will receive ABBV-903 Tablet Form 2 after fasting. Participants will be followed up for 30 days. Receives: Drug: ABBV-903 Tablet Form 1; Drug: ABBV-903 Tablet Form 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AEs)
An 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 Approximately 44 days
Maximum Plasma Concentration (Cmax) of ABBV-903
Cmax of ABBV-903
Measured: Up to approximately 14 days
Time to Cmax (Tmax) of ABBV-903
Tmax of ABBV-903
Measured: Up to approximately 14 days
Terminal Phase Elimination Half-Life (t1/2) of ABBV-903
Terminal phase elimination half-life of ABBV-903
Measured: Up to approximately 14 days
Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-903
AUCt of ABBV-903
Measured: Up to approximately 14 days
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-903
AUCinf of ABBV-903
Measured: Up to approximately 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start18 Apr 2023
- Primary completion20 Jun 2023
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- 24 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
- NCT05836506
- Sponsor's protocol ID
- M24-226
- Status last verified
- Jul 2023
- First submitted
- 20 Apr 2023
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Relative Bioavailability of Immediate Release Formulations of ABBV-903 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05836506
- Acronym / sponsor ID
- M24-226
- Conditions
- Healthy Volunteer
- Keywords
- ABBV-903, Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2023 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 1 May 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 main objective of this study is to assess the relative bioavailability and pharmacokinetics of ABBV-903 in healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1: Sequence A | Experimental | Drug: ABBV-903 Tablet Form 1, Drug: ABBV-903 Tablet Form 2In Period 1 on Day 1, participants will receive ABBV-903 Tablet Form 1 after fasting. In Period 2 on Day 1, participants will receive ABBV-903 Tablet Form 2 after fasting. Lastly, in Period 3 on Day 1, participants will receive ABBV-903 Tablet Form 1 after a high fat meal. Participants will be followed up for 30 days. |
| Part 1: Sequence B | Experimental | Drug: ABBV-903 Tablet Form 1, Drug: ABBV-903 Tablet Form 2In Period 1 on Day 1, participants will receive ABBV-903 Tablet Form 2 after fasting. In Period 2 on Day 1, participants will receive ABBV-903 Tablet Form 1 after fasting. Lastly, in Period 3 on Day 1, participants will receive ABBV-903 Tablet Form 1 after fasting. Participants will be followed up for 30 days. |
| Part 2: Sequence A | Experimental | Drug: ABBV-903 Tablet Form 1, Drug: ABBV-903 Tablet Form 2In Period 1 on Day 1, participants will receive ABBV-903 Tablet Form 1 after fasting. In Period 2 on Day 1, participants will receive ABBV-903 Tablet Form 2 after fasting. Lastly, in Period 3 on Day 1, participants will receive ABBV-903 Tablet Form 2 after a high fat meal. Participants will be followed up for 30 days. |
| Part 2: Sequence B | Experimental | Drug: ABBV-903 Tablet Form 1, Drug: ABBV-903 Tablet Form 2In Period 1 on Day 1, participants will receive ABBV-903 Tablet Form 2 after fasting. In Period 2 on Day 1, participants will receive ABBV-903 Tablet Form 1 after fasting. Lastly, in Period 3 on Day 1, participants will receive ABBV-903 Tablet Form 2 after fasting. Participants will be followed up for 30 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI is ≥ 18.0 to ≤ 32 kg/m2 after rounding to the tenth.
- Negative test result for SARS-CoV-2 infection at screening visit 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 ECG.
Key exclusion criteria (2 listed)
- 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.
- History of diseases aggravated or triggered by ultraviolet radiation and no history of abnormal reaction photosensitivity or photoallergy to sunlight, or artificial source of intense light, especially ultraviolet light.
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-903 Tablet Form 1Oral Tablets | Drug | Part 1: Sequence A, Part 1: Sequence B, Part 2: Sequence A, Part 2: Sequence B |
| ABBV-903 Tablet Form 2Oral Tablets | Drug | Part 1: Sequence A, Part 1: Sequence B, Part 2: Sequence A, Part 2: Sequence B |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: Up to Approximately 44 days
An 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
Maximum Plasma Concentration (Cmax) of ABBV-903
Time frame: Up to approximately 14 days
Cmax of ABBV-903
Time to Cmax (Tmax) of ABBV-903
Time frame: Up to approximately 14 days
Tmax of ABBV-903
Terminal Phase Elimination Half-Life (t1/2) of ABBV-903
Time frame: Up to approximately 14 days
Terminal phase elimination half-life of ABBV-903
Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-903
Time frame: Up to approximately 14 days
AUCt of ABBV-903
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-903
Time frame: Up to approximately 14 days
AUCinf of ABBV-903
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- 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 Tablet Form 1 and ABBV-903 Tablet Form 2 in people with Healthy Volunteer, 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 3 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: finished, as of the sponsor's last update on 17 Jul 2023. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Participants with Adverse Events (AEs) (time frame: Up to Approximately 44 days). The study lists 6 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 17 Jul 2023.