HealthyPhase 1NCT05763459
A Phase 1 Study of ABBV-CLS-7262, Rosuvastatin, and Digoxin in Healthy Subjects
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 follows an open-label, single arm design with two periods with rosuvastatin, digoxin and ABBV-CLS-7262 Read more about this study
- Who is it for?
- Ages 18 to 65 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
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2023to 2 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
- 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 65 years of age inclusive at the time of screening
- 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 the Drug-Drug Interaction Between ABBV-CLS-7262, Rosuvastatin, and Digoxin Following Multiple Doses of ABBV-CLS-7262
This study follows an open-label, single arm design with two periods with rosuvastatin, digoxin and ABBV-CLS-7262
Read the detailed description
Period 1: One single dose of rosuvastatin and one single dose of digoxin on Day 1.
Period 2: Multiple doses of ABBV-CLS-7262 once daily from Day 1 to Day 8. On Day 5, one single dose of rosuvastatin and one single dose of digoxin with the dose of ABBV-CLS-7262 on that day.
- Conditions
- Healthy
- Being tested
- ABBV-CLS-7262
- Keywords
- Digoxin, Rosuvastatin, Molecular Mechanisms of Pharmacological Action, Physiological effects of drugs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-CLS-7262Drug
Drug: ABBV-CLS-7262 Drug: Digoxin Drug: Rosuvastatin
| Study group | Role | What they receive |
|---|---|---|
| ABBV-CLS-7262 | Experimental | ABBV-CLS-7262 + Digoxin + Rosuvastatin Receives: Drug: ABBV-CLS-7262 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of Rosuvastatin
Area under the Curve (AUC)
Measured: Two Weeks
Pharmacokinetics of Digoxin
Area under the Curve (AUC)
Measured: Two Weeks
Secondary outcomes (1)
Safety and Tolerability
Number of patients with treatment-related adverse events as assessed by CTCAE v4.03
Measured: Two Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start24 Mar 2023
- Primary completion8 May 2023
- Study completion2 Jun 2023
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
- 12 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
- NCT05763459
- Sponsor's protocol ID
- M24-192
- Status last verified
- Jun 2023
- First submitted
- 27 Feb 2023
- Last updated
- 26 Jun 2023
- 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 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Drug-Drug Interaction Between ABBV-CLS-7262, Rosuvastatin, and Digoxin Following Multiple Doses of ABBV-CLS-7262
- ClinicalTrials.gov ID
- NCT05763459
- Acronym / sponsor ID
- M24-192
- Conditions
- Healthy
- Keywords
- Digoxin, Rosuvastatin, Molecular Mechanisms of Pharmacological Action, Physiological effects of drugs
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Calico Life Sciences LLCIndustry (pharma, biotech, devices)
- Collaborators
- AbbVie
- Study start
- 24 Mar 2023 (actual)
- Primary completion
- 8 May 2023 (actual)
- Study completion
- 2 Jun 2023 (actual)
- First posted
- 10 Mar 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 follows an open-label, single arm design with two periods with rosuvastatin, digoxin and ABBV-CLS-7262
Detailed description
Period 1: One single dose of rosuvastatin and one single dose of digoxin on Day 1.
Period 2: Multiple doses of ABBV-CLS-7262 once daily from Day 1 to Day 8. On Day 5, one single dose of rosuvastatin and one single dose of digoxin with the dose of ABBV-CLS-7262 on that day.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABBV-CLS-7262 | Experimental | Drug: ABBV-CLS-7262ABBV-CLS-7262 + Digoxin + Rosuvastatin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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 65 years of age inclusive at the time of screening
- 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-7262Drug: ABBV-CLS-7262 Drug: Digoxin Drug: Rosuvastatin | Drug | ABBV-CLS-7262 |
Primary outcome
Pharmacokinetics of Rosuvastatin
Time frame: Two Weeks
Area under the Curve (AUC)
Pharmacokinetics of Digoxin
Time frame: Two Weeks
Area under the Curve (AUC)
1 secondary outcome
Safety and Tolerability
Time frame: Two 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 26 Jun 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.
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 26 Jun 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?
Pharmacokinetics of Rosuvastatin (time frame: 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 26 Jun 2023.