Healthy VolunteersPhase 1NCT04934124
Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteers
A Phase 1 study testing ITI-333 in people with Healthy Volunteers, run by Intra-Cellular Therapies, Inc. at 1 site in United States.
Trial summary
The study will be conducted as a single-center, randomized, double-blind, placebo-controlled, ascending dose study in up to 8 sequential cohorts of healthy subjects. Each cohort will enroll 8 subjects: 6 subjects will receive ITI-333 and 2 subjects will receive placebo as a single oral dose after a fast of at least 10… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ITI-333
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Dec 2020to 23 Aug 2021
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects between 18 and 45 years old (inclusive);
- BMI inclusive of 18-32 kg/m2 at screening and a minimum weight of 50 kg;
- Willingness to remain in the clinic for the inpatient portion of the study and return for follow-up visit(s) as required by protocol and as deemed necessary by the Investigator;
Who cannot join
- Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the subject at risk or interfere with study outcome variables; this includes, but is not limited to, history of or current cardiac, hepatic, renal, neurologic, GI, pulmonary, endocrinologic, hematologic, or immunologic disease or history of malignancy;
- Clinically significant abnormal findings in vital sign assessments, including blood oxygen saturation (SAO2) < 96% and < 12 breaths per min; 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 Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteers
The study will be conducted as a single-center, randomized, double-blind, placebo-controlled, ascending dose study in up to 8 sequential cohorts of healthy subjects. Each cohort will enroll 8 subjects: 6 subjects will receive ITI-333 and 2 subjects will receive placebo as a single oral dose after a fast of at least 10 hours.
- Conditions
- Healthy Volunteers
- Being tested
- ITI-333, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITI-333Drug
ITI-333 oral solution
PlaceboOther
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: 0.03 mg ITI-333 or placebo | Experimental | Not described Receives: Drug: ITI-333; Other: Placebo |
| Cohort 2: 0.09 mg ITI-333 or placebo | Experimental | Not described Receives: Drug: ITI-333; Other: Placebo |
| Cohort 3: 0.25 mg ITI-333 or placebo | Experimental | Not described Receives: Drug: ITI-333; Other: Placebo |
| Cohort 4: 0.75 mg ITI-333 or placebo | Experimental | Not described Receives: Drug: ITI-333; Other: Placebo |
| Cohort 5: 2.25 mg ITI-333 or placebo | Experimental | Not described Receives: Drug: ITI-333; Other: Placebo |
| Cohort 6: 6.75 mg ITI-333 or placebo | Experimental | Not described Receives: Drug: ITI-333; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with treatment-emergent adverse events
Measured: up to 30 days after last dose
Change from baseline in systolic and diastolic blood pressure
Measured: Up to Day 12
Change from baseline in SAO2
Measured: Up to Day 12
Change from baseline in ECG QT interval
Measured: Up to Day 12
Change from baseline in hemoglobin
Measured: Up to Day 12
Change from baseline in white blood cell count
Measured: Up to Day 12
Change from baseline in aspartate aminotransferase
Measured: Up to Day 12
Change from baseline in alanine aminotransferase
Measured: Up to Day 12
Secondary outcomes (7)
Pharmacokinetics: AUC0-t
Area under the plasma concentration time curve from time zero to the last measurable of concentration of ITI-333 and metabolites
Measured: predose and multiple timepoints up to 96 hours postdose
Pharmacokinetics: AUC0-inf
Area under the plasma concentration (ITI-333 and metabolites) time curve from time zero to infinity
Measured: predose and multiple timepoints up to 96 hours postdose
Pharmacokinetics: Cmax
Maximum plasma concentration of ITI-333 and metabolites
Measured: predose and multiple timepoints up to 96 hours postdose
Pharmacokinetics: Tmax
Time of maximum concentration of ITI-333 and metabolites in plasma
Measured: predose and multiple timepoints up to 96 hours postdose
Pharmacokinetics: T1/2
Terminal elimination half-life of ITI-333 and metabolites
Measured: predose and multiple timepoints up to 96 hours postdose
Pharmacokinetics: CL/F
Apparent oral clearance of ITI-333
Measured: predose and multiple timepoints up to 96 hours postdose
Pharmacokinetics: Vz/F
Apparent volume of distribution of ITI-333
Measured: predose and multiple timepoints up to 96 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start23 Dec 2020
- Primary completion23 Aug 2021
- Study completion23 Aug 2021
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
- Randomised
- Intervention model
- Sequential
- Model description
- Sequential ascending doses. Parallel (active, placebo) within each cohort
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intra-Cellular Therapies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934124
- Sponsor's protocol ID
- ITI-333-001
- Other IDs
- 1UG3DA047699-01
- Status last verified
- Mar 2023
- First submitted
- 14 Jun 2021
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04934124
- Acronym / sponsor ID
- ITI-333-001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Intra-Cellular Therapies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 23 Dec 2020 (actual)
- Primary completion
- 23 Aug 2021 (actual)
- Study completion
- 23 Aug 2021 (actual)
- First posted
- 22 Jun 2021 (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 study will be conducted as a single-center, randomized, double-blind, placebo-controlled, ascending dose study in up to 8 sequential cohorts of healthy subjects. Each cohort will enroll 8 subjects: 6 subjects will receive ITI-333 and 2 subjects will receive placebo as a single oral dose after a fast of at least 10 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- Sequential ascending doses. Parallel (active, placebo) within each cohort
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: 0.03 mg ITI-333 or placebo | Experimental | Drug: ITI-333, Other: Placebo |
| Cohort 2: 0.09 mg ITI-333 or placebo | Experimental | Drug: ITI-333, Other: Placebo |
| Cohort 3: 0.25 mg ITI-333 or placebo | Experimental | Drug: ITI-333, Other: Placebo |
| Cohort 4: 0.75 mg ITI-333 or placebo | Experimental | Drug: ITI-333, Other: Placebo |
| Cohort 5: 2.25 mg ITI-333 or placebo | Experimental | Drug: ITI-333, Other: Placebo |
| Cohort 6: 6.75 mg ITI-333 or placebo | Experimental | Drug: ITI-333, Other: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male and female subjects between 18 and 45 years old (inclusive);
- BMI inclusive of 18-32 kg/m2 at screening and a minimum weight of 50 kg;
- Willingness to remain in the clinic for the inpatient portion of the study and return for follow-up visit(s) as required by protocol and as deemed necessary by the Investigator;
Key exclusion criteria (2 listed)
- Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the subject at risk or interfere with study outcome variables; this includes, but is not limited to, history of or current cardiac, hepatic, renal, neurologic, GI, pulmonary, endocrinologic, hematologic, or immunologic disease or history of malignancy;
- Clinically significant abnormal findings in vital sign assessments, including blood oxygen saturation (SAO2) < 96% and < 12 breaths per min; History of psychiatric condition that in the Investigator's opinion may be detrimental to participation in the study
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 |
|---|---|---|
| ITI-333ITI-333 oral solution | Drug | Cohort 1: 0.03 mg ITI-333 or placebo, Cohort 2: 0.09 mg ITI-333 or placebo, Cohort 3: 0.25 mg ITI-333 or placebo, Cohort 4: 0.75 mg ITI-333 or placebo, Cohort 5: 2.25 mg ITI-333 or placebo, Cohort 6: 6.75 mg ITI-333 or placebo |
| PlaceboMatching placebo | Other | Cohort 1: 0.03 mg ITI-333 or placebo, Cohort 2: 0.09 mg ITI-333 or placebo, Cohort 3: 0.25 mg ITI-333 or placebo, Cohort 4: 0.75 mg ITI-333 or placebo, Cohort 5: 2.25 mg ITI-333 or placebo, Cohort 6: 6.75 mg ITI-333 or placebo |
Primary outcome
Percentage of subjects with treatment-emergent adverse events
Time frame: up to 30 days after last dose
Change from baseline in systolic and diastolic blood pressure
Time frame: Up to Day 12
Change from baseline in SAO2
Time frame: Up to Day 12
Change from baseline in ECG QT interval
Time frame: Up to Day 12
Change from baseline in hemoglobin
Time frame: Up to Day 12
Change from baseline in white blood cell count
Time frame: Up to Day 12
Change from baseline in aspartate aminotransferase
Time frame: Up to Day 12
Change from baseline in alanine aminotransferase
Time frame: Up to Day 12
7 secondary outcomes
Pharmacokinetics: AUC0-t
Time frame: predose and multiple timepoints up to 96 hours postdose
Pharmacokinetics: AUC0-inf
Time frame: predose and multiple timepoints up to 96 hours postdose
Pharmacokinetics: Cmax
Time frame: predose and multiple timepoints up to 96 hours postdose
Pharmacokinetics: Tmax
Time frame: predose and multiple timepoints up to 96 hours postdose
Pharmacokinetics: T1/2
Time frame: predose and multiple timepoints up to 96 hours postdose
Pharmacokinetics: CL/F
Time frame: predose and multiple timepoints up to 96 hours postdose
Pharmacokinetics: Vz/F
Time frame: predose and multiple timepoints up to 96 hours postdose
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 14 Mar 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 ITI-333 in people with Healthy Volunteers, run by Intra-Cellular Therapies, Inc. 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 3 inclusion and 2 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 14 Mar 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?
Percentage of subjects with treatment-emergent adverse events (time frame: up to 30 days after last dose). The study lists 8 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 14 Mar 2023.