Healthy VolunteersPhase 1NCT06786286
A Mass Balance Study Following Subcutaneous Administration of [14C]-ITI-1284 to Healthy Male Subjects
A Phase 1 study testing [14C]-ITI-1284 in people with Healthy Volunteers, run by Intra-Cellular Therapies, Inc. at 1 site in United Kingdom.
Trial summary
ITI-1284-012 is an open-label, single-dose study to assess the mass balance recovery of radioactivity, and to evaluate the pharmacokinetics, safety and tolerability of ITI-1284 after a single subcutaneous dose of [14C]-ITI-1284 in healthy male subjects. Read more about this study
- Who is it for?
- Ages 30 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- [14C]-ITI-1284
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Jan 2025to 26 Mar 2025
- 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 30 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects between 30 and 55 years of age (inclusive);
- BMI between18.0 and 32.0 kg/m2, inclusive, at screening, and a minimum body weight of 50 kg at screening;
- Willing to be confined to the clinical research unit for the duration of the inpatient period of the study.
Who cannot join
- Radiation exposure, including that from the present study, excluding background radiation but including diagnostic X-rays and other medical exposure, exceeding 5 mSev in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker shall participate in the study;
- Subjects who have been enrolled in a 14C-labeled product study in the 10 months prior to dosing with study drug on Day 1;
- Any clinical condition or procedure that may affect the absorption, distribution, biotransformation, or excretion of ITI-1284. Subjects with a history of appendectomy and/or abdominal wall hernia repair are eligible for study participation provided surgery was performed ≥1 year ago;
- Acute diarrhea or constipation in the 7 days before Day 1. If screening occurs > 7 days before Day 1, this criterion will be determined on Day 1;
- Clinically significant abnormal findings in vital sign assessments, supine SBP > 140 mmHg or < 90 mmHg, or supine DBP >90 mmHg or < 50 mmHg or supine pulse rate > 100 bpm or < 45 bpm at Screening;
- History of psychiatric condition that in the Investigator's opinion may be detrimental to participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label Study to Assess the Mass Balance, Metabolism, Excretion and Pharmacokinetics of a Single Subcutaneous Dose of [14C]-ITI-1284 in Healthy Male Subjects
ITI-1284-012 is an open-label, single-dose study to assess the mass balance recovery of radioactivity, and to evaluate the pharmacokinetics, safety and tolerability of ITI-1284 after a single subcutaneous dose of [14C]-ITI-1284 in healthy male subjects.
- Conditions
- Healthy Volunteers
- Being tested
- [14C]-ITI-1284
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-ITI-1284Drug
[14C]-ITI-1284 20 mg oral solution (not more than 22 μCi), subcutaneous administration
| Study group | Role | What they receive |
|---|---|---|
| [14C]-ITI-1284 20 mg | Experimental | Not described Receives: Drug: [14C]-ITI-1284 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass balance recovery of total radioactivity in urine and feces combined
percentage of total radioactivity
Measured: Day 1 up to Day 29
Pharmacokinetics: AUC0-t for total radioactivity
Area under the plasma drug concentration-time curve (AUC) from time zero to the last measurable concentration
Measured: Day 1 up to Day 29
Pharmacokinetics: AUC0-t for ITI-1284
Area under the plasma drug concentration-time curve (AUC) from time zero to the last measurable concentration
Measured: Day 1 to Day 8
Pharmacokinetics: Cmax for total radioactivity
Maximum plasma concentration
Measured: Day 1 up to Day 29
Pharmacokinetics: Cmax for ITI-1284
Maximum plasma concentration
Measured: Day 1 to Day 8
Pharmacokinetics: Tmax for total radioactivity
Time of maximum plasma concentration
Measured: Day 1 up to Day 29
Pharmacokinetics: Tmax for ITI-1284
Time of maximum plasma concentration
Measured: Day 1 to Day 8
Secondary outcomes (3)
Percentage of subjects with treatment-emergent adverse events
Measured: Up to 30 days after the dose of study drug
Change from baseline in systolic and diastolic blood pressure
Measured: Day 14
Change from baseline in ECG QT interval
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start28 Jan 2025
- Primary completion26 Mar 2025
- Study completion26 Mar 2025
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 Intra-Cellular Therapies, Inc.The 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intra-Cellular Therapies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786286
- Sponsor's protocol ID
- ITI-1284-012
- Status last verified
- Apr 2025
- First submitted
- 15 Jan 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study to Assess the Mass Balance, Metabolism, Excretion and Pharmacokinetics of a Single Subcutaneous Dose of [14C]-ITI-1284 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT06786286
- Acronym / sponsor ID
- ITI-1284-012
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Intra-Cellular Therapies, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Jan 2025 (actual)
- Primary completion
- 26 Mar 2025 (actual)
- Study completion
- 26 Mar 2025 (actual)
- First posted
- 22 Jan 2025 (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.
ITI-1284-012 is an open-label, single-dose study to assess the mass balance recovery of radioactivity, and to evaluate the pharmacokinetics, safety and tolerability of ITI-1284 after a single subcutaneous dose of [14C]-ITI-1284 in healthy male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]-ITI-1284 20 mg | Experimental | Drug: [14C]-ITI-1284 |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male subjects between 30 and 55 years of age (inclusive);
- BMI between18.0 and 32.0 kg/m2, inclusive, at screening, and a minimum body weight of 50 kg at screening;
- Willing to be confined to the clinical research unit for the duration of the inpatient period of the study.
Key exclusion criteria (6 listed)
- Radiation exposure, including that from the present study, excluding background radiation but including diagnostic X-rays and other medical exposure, exceeding 5 mSev in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker shall participate in the study;
- Subjects who have been enrolled in a 14C-labeled product study in the 10 months prior to dosing with study drug on Day 1;
- Any clinical condition or procedure that may affect the absorption, distribution, biotransformation, or excretion of ITI-1284. Subjects with a history of appendectomy and/or abdominal wall hernia repair are eligible for study participation provided surgery was performed ≥1 year ago;
- Acute diarrhea or constipation in the 7 days before Day 1. If screening occurs > 7 days before Day 1, this criterion will be determined on Day 1;
- Clinically significant abnormal findings in vital sign assessments, supine SBP > 140 mmHg or < 90 mmHg, or supine DBP >90 mmHg or < 50 mmHg or supine pulse rate > 100 bpm or < 45 bpm at Screening;
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]-ITI-1284[14C]-ITI-1284 20 mg oral solution (not more than 22 μCi), subcutaneous administration | Drug | [14C]-ITI-1284 20 mg |
Primary outcome
Mass balance recovery of total radioactivity in urine and feces combined
Time frame: Day 1 up to Day 29
percentage of total radioactivity
Pharmacokinetics: AUC0-t for total radioactivity
Time frame: Day 1 up to Day 29
Area under the plasma drug concentration-time curve (AUC) from time zero to the last measurable concentration
Pharmacokinetics: AUC0-t for ITI-1284
Time frame: Day 1 to Day 8
Area under the plasma drug concentration-time curve (AUC) from time zero to the last measurable concentration
Pharmacokinetics: Cmax for total radioactivity
Time frame: Day 1 up to Day 29
Maximum plasma concentration
Pharmacokinetics: Cmax for ITI-1284
Time frame: Day 1 to Day 8
Maximum plasma concentration
Pharmacokinetics: Tmax for total radioactivity
Time frame: Day 1 up to Day 29
Time of maximum plasma concentration
Pharmacokinetics: Tmax for ITI-1284
Time frame: Day 1 to Day 8
Time of maximum plasma concentration
3 secondary outcomes
Percentage of subjects with treatment-emergent adverse events
Time frame: Up to 30 days after the dose of study drug
Change from baseline in systolic and diastolic blood pressure
Time frame: Day 14
Change from baseline in ECG QT interval
Time frame: Day 14
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 16 Apr 2025.
- 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 [14C]-ITI-1284 in people with Healthy Volunteers, run by Intra-Cellular Therapies, Inc. at 1 site in United Kingdom.
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 3 inclusion and 6 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 16 Apr 2025. 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 Kingdom. 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?
Mass balance recovery of total radioactivity in urine and feces combined (time frame: Day 1 up to Day 29). 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 16 Apr 2025.