HealthyPhase 1NCT06310876
A Thorough QT Study of ABBV-CLS-7262 in Healthy Subjects
A Phase 1 study testing ABBV-CLS-7262 and Moxifloxacin 400mg in people with Healthy, run by Calico Life Sciences LLC at 1 site in United States.
Trial summary
This is a randomized, blinded, placebo and active-controlled, 4-period, crossover design thorough QT/QTc (TQT) study to evaluate the effect of ABBV-CLS-7262 on cardiac repolarization 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 and Moxifloxacin 400mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2024to 26 Jun 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 ≤ 29.9 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 Placebo-and Active-Controlled Crossover Study of the Potential for Cardiac Repolarization Effects Following Single Dose of ABBV-CLS-7262 in Healthy Subjects
This is a randomized, blinded, placebo and active-controlled, 4-period, crossover design thorough QT/QTc (TQT) study to evaluate the effect of ABBV-CLS-7262 on cardiac repolarization in healthy adult subjects.
Read the detailed description
This is a randomized, blinded, placebo and active-controlled, 4-period, crossover study. The study will be double-blinded for ABBV-CLS-7262 (dose 1 or dose 2) and placebo regimens and open-label for moxifloxacin. 72 subjects are planned to be enrolled.
All subjects will receive a single oral dose of 4 different study treatments over 4 separate treatment periods, each separated by a washout period.
On Day 1 of each period, subjects will receive either ABBV-CLS-7262 dose 1, ABBV-CLS-7262 dose 2, placebo, or moxifloxacin 400 mg.
In each period, cardiodynamic ECGs will be collected pre-dose and for 24 hours post-dose and PK blood samples will be collected pre-dose and for 48 hours post-dose. Safety will be monitored throughout the study by repeated clinical and laboratory evaluations.
- Conditions
- Healthy
- Being tested
- ABBV-CLS-7262, Placebo, Moxifloxacin 400mg
- Keywords
- TQT, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-CLS-7262Drug
- single oral Dose 1
ABBV-CLS-7262Drug
- single oral Dose 2
PlaceboDrug
- single oral dose
Moxifloxacin 400mgDrug
- single oral dose
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Subjects will receive ABBV-CLS-7262 dose 1, ABBV-CLS-7262 dose 2, placebo, or moxifloxacin 400 mg tablet Receives: Drug: ABBV-CLS-7262; Drug: Placebo; Drug: Moxifloxacin 400mg |
| Sequence 2 | Experimental | Subjects will receive ABBV-CLS-7262 dose 1, ABBV-CLS-7262 dose 2, placebo, or moxifloxacin 400 mg tablet Receives: Drug: ABBV-CLS-7262; Drug: Placebo; Drug: Moxifloxacin 400mg |
| Sequence 3 | Experimental | Subjects will receive ABBV-CLS-7262 dose 1, ABBV-CLS-7262 dose 2, placebo, or moxifloxacin 400 mg tablet Receives: Drug: ABBV-CLS-7262; Drug: Placebo; Drug: Moxifloxacin 400mg |
| Sequence 4 | Experimental | Subjects will receive ABBV-CLS-7262 dose 1, ABBV-CLS-7262 dose 2, placebo, or moxifloxacin 400 mg tablet Receives: Drug: ABBV-CLS-7262; Drug: Placebo; Drug: Moxifloxacin 400mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of ABBV-CLS-7262 on the QTc interval in healthy adult subjects
To evaluate the effect of ABBV-CLS-7262 on the QTc interval in healthy adult subjects.
Measured: Up to 24 hours
Secondary outcomes (3)
To evaluate the effects of ABBV-CLS-7262 on change in electrocardiogram (ECG) parameters
ECG parameters include RR and PR interval, QRS duration and heart rate (HR).
Measured: Up to 24 hours
To evaluate the sensitivity of QTc measurement using moxifloxacin
To evaluate the sensitivity of QTc measurement using moxifloxacin.
Measured: Up to 24 hours
To evaluate the effect of ABBV-CLS-7262 on T-wave morphology
To evaluate the effect of ABBV-CLS-7262 on T-wave morphology.
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start14 Mar 2024
- Primary completion29 May 2024
- Study completion26 Jun 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 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
- NCT06310876
- Sponsor's protocol ID
- M24-852
- Status last verified
- Jun 2024
- First submitted
- 4 Mar 2024
- Last updated
- 1 Jul 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 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Placebo-and Active-Controlled Crossover Study of the Potential for Cardiac Repolarization Effects Following Single Dose of ABBV-CLS-7262 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06310876
- Acronym / sponsor ID
- M24-852
- Conditions
- Healthy
- Keywords
- TQT, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Calico Life Sciences LLCIndustry (pharma, biotech, devices)
- Collaborators
- AbbVie
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- 29 May 2024 (actual)
- Study completion
- 26 Jun 2024 (actual)
- First posted
- 15 Mar 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.
This is a randomized, blinded, placebo and active-controlled, 4-period, crossover design thorough QT/QTc (TQT) study to evaluate the effect of ABBV-CLS-7262 on cardiac repolarization in healthy adult subjects.
Detailed description
This is a randomized, blinded, placebo and active-controlled, 4-period, crossover study. The study will be double-blinded for ABBV-CLS-7262 (dose 1 or dose 2) and placebo regimens and open-label for moxifloxacin. 72 subjects are planned to be enrolled.
All subjects will receive a single oral dose of 4 different study treatments over 4 separate treatment periods, each separated by a washout period.
On Day 1 of each period, subjects will receive either ABBV-CLS-7262 dose 1, ABBV-CLS-7262 dose 2, placebo, or moxifloxacin 400 mg.
In each period, cardiodynamic ECGs will be collected pre-dose and for 24 hours post-dose and PK blood samples will be collected pre-dose and for 48 hours post-dose. Safety will be monitored throughout the study by repeated clinical and laboratory evaluations.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: ABBV-CLS-7262, Drug: Placebo, Drug: Moxifloxacin 400mgSubjects will receive ABBV-CLS-7262 dose 1, ABBV-CLS-7262 dose 2, placebo, or moxifloxacin 400 mg tablet |
| Sequence 2 | Experimental | Drug: ABBV-CLS-7262, Drug: Placebo, Drug: Moxifloxacin 400mgSubjects will receive ABBV-CLS-7262 dose 1, ABBV-CLS-7262 dose 2, placebo, or moxifloxacin 400 mg tablet |
| Sequence 3 | Experimental | Drug: ABBV-CLS-7262, Drug: Placebo, Drug: Moxifloxacin 400mgSubjects will receive ABBV-CLS-7262 dose 1, ABBV-CLS-7262 dose 2, placebo, or moxifloxacin 400 mg tablet |
| Sequence 4 | Experimental | Drug: ABBV-CLS-7262, Drug: Placebo, Drug: Moxifloxacin 400mgSubjects will receive ABBV-CLS-7262 dose 1, ABBV-CLS-7262 dose 2, placebo, or moxifloxacin 400 mg tablet |
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 ≤ 29.9 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-7262• single oral Dose 1 | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| ABBV-CLS-7262• single oral Dose 2 | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| Placebo• single oral dose | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| Moxifloxacin 400mg• single oral dose | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
Primary outcome
To evaluate the effect of ABBV-CLS-7262 on the QTc interval in healthy adult subjects
Time frame: Up to 24 hours
To evaluate the effect of ABBV-CLS-7262 on the QTc interval in healthy adult subjects.
3 secondary outcomes
To evaluate the effects of ABBV-CLS-7262 on change in electrocardiogram (ECG) parameters
Time frame: Up to 24 hours
To evaluate the sensitivity of QTc measurement using moxifloxacin
Time frame: Up to 24 hours
To evaluate the effect of ABBV-CLS-7262 on T-wave morphology
Time frame: Up to 24 hours
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 1 Jul 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 and Moxifloxacin 400mg 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 1 Jul 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 evaluate the effect of ABBV-CLS-7262 on the QTc interval in healthy adult subjects (time frame: Up to 24 hours). 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 1 Jul 2024.