Healthy VolunteersPhase 1NCT06477926
A Study to Assess Relative Bioavailability and Food Effect of ABBV-668 Extended-Release Formulations in Adult Participants
A Phase 1 study testing ABBV-668 IR and ABBV-668 ER in people with Healthy Volunteers, run by AbbVie at 1 site in United States.
Trial summary
The objectives of this study are to assess safety and tolerability of the new ABBV-668 ER tablets, to assess the oral bioavailability of the ABBV-668 ER tablets relative to the ABBV-668 IR capsules, and to assess the pharmacokinetics of the ER tablets under fasting and fed conditions in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ABBV-668 IR and ABBV-668 ER
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2024to 20 Sep 2024
- 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 60 years
- All sexes
- Healthy volunteers accepted
- 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 any clinically significant sensitivity or allergy to any medication or food.
- History of any investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug or is currently enrolled in another clinical study or was previously enrolled in this study.
- 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.
- Participant using any medication, vitamins and/or herbal supplements (including traditional Chinese medicine), with the exception of hormonal replacement therapies for females, on a regular basis.
- Any use of tobacco or nicotine-containing products within 180 days prior to the first dose of study drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Relative Bioavailability and Food Effect Study of ABBV-668 Extended-Release Formulations
The objectives of this study are to assess safety and tolerability of the new ABBV-668 ER tablets, to assess the oral bioavailability of the ABBV-668 ER tablets relative to the ABBV-668 IR capsules, and to assess the pharmacokinetics of the ER tablets under fasting and fed conditions in healthy adults.
- Conditions
- Healthy Volunteers
- Being tested
- ABBV-668 IR, ABBV-668 ER
- Keywords
- Healthy Volunteers, ABBV-668
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-668 IRDrug
- Oral Capsule
ABBV-668 ERDrug
- Oral Tablets
| Study group | Role | What they receive |
|---|---|---|
| ABBV-668 Regimen A | Experimental | Participants will receive ABBV-668 Immediate Release (IR) capsules on Day 1 under fasting conditions Receives: Drug: ABBV-668 IR |
| ABBV-668 Regimen B | Experimental | Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 1 administered on day 1 under fasting conditions Receives: Drug: ABBV-668 ER |
| ABBV-668 Regimen C | Experimental | Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 1 administered on day 1 under fed conditions Receives: Drug: ABBV-668 ER |
| ABBV-668 Regimen D | Experimental | Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 2 administered on day 1 under fasting conditions Receives: Drug: ABBV-668 ER |
| ABBV-668 Regimen E | Experimental | Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 2 administered on day 1 under fed conditions Receives: Drug: ABBV-668 ER |
| ABBV-668 Regimen F | Experimental | Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 3 administered on day 1 under fasting conditions Receives: Drug: ABBV-668 ER |
| ABBV-668 Regimen G | Experimental | Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 3 administered on day 1 under fed conditions Receives: Drug: ABBV-668 ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) of ABBV-668
Cmax of ABBV-668
Measured: Up to approximately 47 days
Time to Cmax (Tmax) of ABBV-668
Tmax of ABBV-668
Measured: Up to approximately 47 days
Terminal Phase Elimination Rate Constant (Beta) of ABBV-668
Terminal phase elimination rate constant (beta) of ABBV-668
Measured: Up to approximately 47 days
Terminal Phase Elimination Half-Life (t1/2) of ABBV-668
Terminal phase elimination half-life of ABBV-668
Measured: Up to approximately 47 days
Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-668
AUCt of ABBV-668
Measured: Up to approximately 47 days
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-688
AUCinf of ABBV-688
Measured: Up to approximately 47 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 47
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start9 Jul 2024
- Primary completion20 Sep 2024
- Study completion20 Sep 2024
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 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
- NCT06477926
- Sponsor's protocol ID
- M25-176
- Status last verified
- Oct 2024
- First submitted
- 24 Jun 2024
- Last updated
- 8 Oct 2024
- 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 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Relative Bioavailability and Food Effect Study of ABBV-668 Extended-Release Formulations
- ClinicalTrials.gov ID
- NCT06477926
- Acronym / sponsor ID
- M25-176
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Volunteers, ABBV-668
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 9 Jul 2024 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 27 Jun 2024 (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 objectives of this study are to assess safety and tolerability of the new ABBV-668 ER tablets, to assess the oral bioavailability of the ABBV-668 ER tablets relative to the ABBV-668 IR capsules, and to assess the pharmacokinetics of the ER tablets under fasting and fed conditions in healthy adults.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| ABBV-668 Regimen A | Experimental | Drug: ABBV-668 IRParticipants will receive ABBV-668 Immediate Release (IR) capsules on Day 1 under fasting conditions |
| ABBV-668 Regimen B | Experimental | Drug: ABBV-668 ERParticipants will receive ABBV-668 Extended Release (ER) tablets Formulation 1 administered on day 1 under fasting conditions |
| ABBV-668 Regimen C | Experimental | Drug: ABBV-668 ERParticipants will receive ABBV-668 Extended Release (ER) tablets Formulation 1 administered on day 1 under fed conditions |
| ABBV-668 Regimen D | Experimental | Drug: ABBV-668 ERParticipants will receive ABBV-668 Extended Release (ER) tablets Formulation 2 administered on day 1 under fasting conditions |
| ABBV-668 Regimen E | Experimental | Drug: ABBV-668 ERParticipants will receive ABBV-668 Extended Release (ER) tablets Formulation 2 administered on day 1 under fed conditions |
| ABBV-668 Regimen F | Experimental | Drug: ABBV-668 ERParticipants will receive ABBV-668 Extended Release (ER) tablets Formulation 3 administered on day 1 under fasting conditions |
| ABBV-668 Regimen G | Experimental | Drug: ABBV-668 ERParticipants will receive ABBV-668 Extended Release (ER) tablets Formulation 3 administered on day 1 under fed conditions |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- History of any clinically significant sensitivity or allergy to any medication or food.
- History of any investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug or is currently enrolled in another clinical study or was previously enrolled in this study.
- 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.
- Participant using any medication, vitamins and/or herbal supplements (including traditional Chinese medicine), with the exception of hormonal replacement therapies for females, on a regular basis.
- Any use of tobacco or nicotine-containing products within 180 days prior to the first dose of study drug.
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-668 IR• Oral Capsule | Drug | ABBV-668 Regimen A |
| ABBV-668 ER• Oral Tablets | Drug | ABBV-668 Regimen B, ABBV-668 Regimen C, ABBV-668 Regimen D, ABBV-668 Regimen E, ABBV-668 Regimen F, ABBV-668 Regimen G |
Primary outcome
Maximum Plasma Concentration (Cmax) of ABBV-668
Time frame: Up to approximately 47 days
Cmax of ABBV-668
Time to Cmax (Tmax) of ABBV-668
Time frame: Up to approximately 47 days
Tmax of ABBV-668
Terminal Phase Elimination Rate Constant (Beta) of ABBV-668
Time frame: Up to approximately 47 days
Terminal phase elimination rate constant (beta) of ABBV-668
Terminal Phase Elimination Half-Life (t1/2) of ABBV-668
Time frame: Up to approximately 47 days
Terminal phase elimination half-life of ABBV-668
Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-668
Time frame: Up to approximately 47 days
AUCt of ABBV-668
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-688
Time frame: Up to approximately 47 days
AUCinf of ABBV-688
Number of Participants With Adverse Events (AEs)
Time frame: Up to Day 47
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
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 8 Oct 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-668 IR and ABBV-668 ER 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 5 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 8 Oct 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 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?
Maximum Plasma Concentration (Cmax) of ABBV-668 (time frame: Up to approximately 47 days). The study lists 7 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 8 Oct 2024.