HealthyPhase 1NCT06145607
A Phase 1 Study Assessing the Effect of Food on the Pharmacokinetics of ABBV- CLS-7262
A Phase 1 study testing ABBV-CLS-7262 in people with Healthy, run by Calico Life Sciences LLC at 1 site in United States.
Trial summary
This study is a randomized, three period, six sequence, single dose crossover design with ABBV-CLS-7262 in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ABBV-CLS-7262
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2023to 26 Feb 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult volunteers in general good health.
- Must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures.
- Individuals between 18 and 55 years of age inclusive at the time of screening.
- Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m2.
- All male subjects who are sexually active and not surgically sterilized must agree to use an acceptable contraceptive method. Additionally, male subjects must agree to not donate sperm during the study until 30 days after the final dose of study drug.
- All female subjects who are sexually active and of childbearing potential must agree to use a highly effective contraceptive method. Additionally, female subjects must agree to not donate eggs during the study and for 30 days after the final dose of study drug.
Who cannot join
- Subject who, in the opinion of the investigator, is incapable of completing study-required visits and procedures
- Pregnant or breastfeeding.
- Treatment with any other investigational treatment within 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
AbbVie Clinical Pharmacology Research Unit (ACPRU)
Grayslake, Illinois, 60030
About this study
Official title: A Phase 1 Study to Evaluate Safety, Tolerability, and Food-Effect Following Administration of ABBV-CLS-7262 in Healthy Volunteers
This study is a randomized, three period, six sequence, single dose crossover design with ABBV-CLS-7262 in healthy adult subjects.
Read the detailed description
On Day 1 of each period, subjects will receive a single oral dose of ABBV-CLS-7262 administered according to the food regimen assigned. There will be a 4-day washout period between doses. Food regimens include administration after fasting, following a high-fat/high-calorie meal, or with apple sauce. Upon completion each subject will have taken a total of three doses of ABBV-CLS-7262, with one dose administered with each food regimen.
- Conditions
- Healthy
- Being tested
- ABBV-CLS-7262
- Keywords
- Food effect, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-CLS-7262Drug
ABBV-CLS-7262
| Study group | Role | What they receive |
|---|---|---|
| Period 1, 2 and 3 ABBV-CLS-7262 | Experimental | * Participants will receive ABBV-CLS-7262 administered under fasted conditions.
* Participants will receive ABBV-CLS-7262 administered under fed conditions (high-fat/high-calorie breakfast).
* Participants will receive ABBV-CLS-7262 administered with applesauce. Receives: Drug: ABBV-CLS-7262 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the pharmacokinetics following a single oral dose of ABBV-CLS-7262 taken with or without food.
Maximum Plasma Concentration [Cmax]; Area under the Curve (AUC)
Measured: Approximately Two Weeks
To assess the pharmacokinetics following a single oral dose of ABBV-CLS-7262 administered with or without applesauce.
Maximum Plasma Concentration [Cmax]; Area under the Curve (AUC)
Measured: Approximately Two Weeks
Secondary outcomes (1)
Safety and Tolerability
Number of patients with treatment-related adverse events as assessed by NCI CTCAE v4.03
Measured: Approximately Six Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start19 Dec 2023
- Primary completion30 Jan 2024
- Study completion26 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calico Life Sciences LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AbbVie
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145607
- Sponsor's protocol ID
- M24-851
- Status last verified
- Mar 2024
- First submitted
- 17 Nov 2023
- Last updated
- 8 Mar 2024
- Results posted
- 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 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate Safety, Tolerability, and Food-Effect Following Administration of ABBV-CLS-7262 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06145607
- Acronym / sponsor ID
- M24-851
- Conditions
- Healthy
- Keywords
- Food effect, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Calico Life Sciences LLCIndustry (pharma, biotech, devices)
- Collaborators
- AbbVie
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 26 Feb 2024 (actual)
- First posted
- 24 Nov 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.
This study is a randomized, three period, six sequence, single dose crossover design with ABBV-CLS-7262 in healthy adult subjects.
Detailed description
On Day 1 of each period, subjects will receive a single oral dose of ABBV-CLS-7262 administered according to the food regimen assigned. There will be a 4-day washout period between doses. Food regimens include administration after fasting, following a high-fat/high-calorie meal, or with apple sauce. Upon completion each subject will have taken a total of three doses of ABBV-CLS-7262, with one dose administered with each food regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Period 1, 2 and 3 ABBV-CLS-7262 | Experimental | Drug: ABBV-CLS-7262* Participants will receive ABBV-CLS-7262 administered under fasted conditions. * Participants will receive ABBV-CLS-7262 administered under fed conditions (high-fat/high-calorie breakfast). * Participants will receive ABBV-CLS-7262 administered with applesauce. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adult volunteers in general good health.
- Must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures.
- Individuals between 18 and 55 years of age inclusive at the time of screening.
- Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m2.
- All male subjects who are sexually active and not surgically sterilized must agree to use an acceptable contraceptive method. Additionally, male subjects must agree to not donate sperm during the study until 30 days after the final dose of study drug.
Key exclusion criteria (3 listed)
- Subject who, in the opinion of the investigator, is incapable of completing study-required visits and procedures
- Pregnant or breastfeeding.
- Treatment with any other investigational treatment within 30 days
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-CLS-7262ABBV-CLS-7262 | Drug | Period 1, 2 and 3 ABBV-CLS-7262 |
Primary outcome
To assess the pharmacokinetics following a single oral dose of ABBV-CLS-7262 taken with or without food.
Time frame: Approximately Two Weeks
Maximum Plasma Concentration [Cmax]; Area under the Curve (AUC)
To assess the pharmacokinetics following a single oral dose of ABBV-CLS-7262 administered with or without applesauce.
Time frame: Approximately Two Weeks
Maximum Plasma Concentration [Cmax]; Area under the Curve (AUC)
1 secondary outcome
Safety and Tolerability
Time frame: Approximately Six Weeks
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 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
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-CLS-7262 in people with Healthy, run by Calico Life Sciences LLC 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 6 inclusion and 3 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 Mar 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?
To assess the pharmacokinetics following a single oral dose of ABBV-CLS-7262 taken with or without food. (time frame: Approximately Two Weeks). The study lists 2 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 Mar 2024.