Healthy VolunteerPhase 1NCT06425003
Study of [14C] ABBV-CLS-7262 in Healthy Male Volunteers Following Single Oral Dose Administration
A Phase 1 study testing [14C] ABBV-CLS-7262 in people with Healthy Volunteer, run by Calico Life Sciences LLC at 1 site in United States.
Trial summary
The purpose of this study is to evaluate mass balance, pharmacokinetics and safety of [14C] ABBV-CLS-7262 in healthy, male volunteers following administration of a single oral dose. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- [14C] ABBV-CLS-7262
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2024to 12 Jul 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- Body Max Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at screening.
Who cannot join
- Considering fathering a child or donating sperm during the study and for 94 days after study drug administration, or is unwilling to comply with protocol recommended contraception recommendations.
- History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
- History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, metabolic, renal, hepatic, gastrointestinal, hematologic, endocrinologic or psychiatric disease or disorder, or any uncontrolled medical illness.
- Has had significant exposure to radiation for professional or medical reasons (e.g., serial x-rays or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring), except dental x-rays, within 12 months prior to study drug administration.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fortrea Clinical Research Unit Inc.
Madison, Wisconsin, 53704
About this study
Official title: Mass Balance Study of [14C] ABBV-CLS-7262 in Healthy Male Volunteers Following Single Oral Dose Administration
The purpose of this study is to evaluate mass balance, pharmacokinetics and safety of [14C] ABBV-CLS-7262 in healthy, male volunteers following administration of a single oral dose.
- Conditions
- Healthy Volunteer
- Being tested
- [14C] ABBV-CLS-7262
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C] ABBV-CLS-7262Drug
Oral Solution
| Study group | Role | What they receive |
|---|---|---|
| [14C] ABBV-CLS-7262 | Experimental | Participants will receive [14C] ABBV-CLS-7262 on Day 1. Receives: Drug: [14C] ABBV-CLS-7262 |
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 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.
Measured: Up to approximately 30 days from last dose.
Maximum observed concentration (Cmax)
Cmax will be assessed.
Measured: Up to approximately Day 15 from last dose
Time to Cmax (peak time, Tmax)
Tmax will be assessed.
Measured: Up to approximately 15 days from last dose
Terminal phase elimination half-life (t1/2)
Terminal phase elimination half-life (t1/2) will be assessed.
Measured: Up to approximately 15 days from last dose
Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt)
AUCt will be assessed.
Measured: Up to approximately 15 days from last dose
Percent radioactivity excreted
Percentage total radioactivity
Measured: Up to approximately 15 days from last dose
Identification of metabolites excreted
Identification of the major metabolites
Measured: Up to approximately 15 days from last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start21 May 2024
- Primary completion12 Jul 2024
- Study completion12 Jul 2024
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 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
- NCT06425003
- Sponsor's protocol ID
- M24-326
- Status last verified
- Jul 2024
- First submitted
- 6 May 2024
- Last updated
- 19 Jul 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 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mass Balance Study of [14C] ABBV-CLS-7262 in Healthy Male Volunteers Following Single Oral Dose Administration
- ClinicalTrials.gov ID
- NCT06425003
- Acronym / sponsor ID
- M24-326
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Calico Life Sciences LLCIndustry (pharma, biotech, devices)
- Collaborators
- AbbVie
- Study start
- 21 May 2024 (actual)
- Primary completion
- 12 Jul 2024 (actual)
- Study completion
- 12 Jul 2024 (actual)
- First posted
- 22 May 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 purpose of this study is to evaluate mass balance, pharmacokinetics and safety of [14C] ABBV-CLS-7262 in healthy, male volunteers following administration of a single oral dose.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C] ABBV-CLS-7262 | Experimental | Drug: [14C] ABBV-CLS-7262Participants will receive [14C] ABBV-CLS-7262 on Day 1. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
- Body Max Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at screening.
Key exclusion criteria (4 listed)
- Considering fathering a child or donating sperm during the study and for 94 days after study drug administration, or is unwilling to comply with protocol recommended contraception recommendations.
- History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
- History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, metabolic, renal, hepatic, gastrointestinal, hematologic, endocrinologic or psychiatric disease or disorder, or any uncontrolled medical illness.
- Has had significant exposure to radiation for professional or medical reasons (e.g., serial x-rays or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring), except dental x-rays, within 12 months prior to study drug administration.
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 |
|---|---|---|
| [14C] ABBV-CLS-7262Oral Solution | Drug | [14C] ABBV-CLS-7262 |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: Up to approximately 30 days from last dose.
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.
Maximum observed concentration (Cmax)
Time frame: Up to approximately Day 15 from last dose
Cmax will be assessed.
Time to Cmax (peak time, Tmax)
Time frame: Up to approximately 15 days from last dose
Tmax will be assessed.
Terminal phase elimination half-life (t1/2)
Time frame: Up to approximately 15 days from last dose
Terminal phase elimination half-life (t1/2) will be assessed.
Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt)
Time frame: Up to approximately 15 days from last dose
AUCt will be assessed.
Percent radioactivity excreted
Time frame: Up to approximately 15 days from last dose
Percentage total radioactivity
Identification of metabolites excreted
Time frame: Up to approximately 15 days from last dose
Identification of the major metabolites
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 19 Jul 2024.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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 [14C] ABBV-CLS-7262 in people with Healthy Volunteer, 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 2 inclusion and 4 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 19 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?
Number of Participants with Adverse Events (AEs) (time frame: Up to approximately 30 days from last dose.). 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 19 Jul 2024.