SchizophreniaPhase 1QUARTZNCT06276361

Pharmacokinetics, Safety and Tolerability of Different Formulations and Dose Strengths of Quarterly Risperidone (QUAR) in Patients With Schizophrenia

A Phase 1 study testing Oral risperidone; QUAR F1/2, Dose 1 - Gluteal, Oral risperidone; QUAR F1/2, Dose 2 - Gluteal and Oral risperidone; QUAR F1/2, Dose 3 - Gluteal in people with Schizophrenia, run by Rovi Pharmaceuticals Laboratories at 1 site in Jordan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a single ascending dose phase 1 study to evaluate the pharmacokinetics (PK), safety, and tolerability of a single intramuscular (IM) injection of quarterly Risperidone (QUAR) for different formulations and dose strengths in participants with schizophrenia. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Schizophrenia
What is being tested?: Oral risperidone; QUAR F1/2, Dose 1 - Gluteal, Oral risperidone; QUAR F1/2, Dose 2 - Gluteal and Oral risperidone; QUAR F1/2, Dose 3 - Gluteal
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 1 siteJordan
Study dates: 26 Sep 2023to 7 Jul 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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Capable of providing informed consent.
Male or female aged ≥ 18 years to < 65 years with BMI ≥17.0 to ≤35.0 kg/m2
Current diagnosis of schizophrenia, according to the Diagnostic and DSM-5 criteria.
Medically stable over the last month, and psychiatrically stable without significant symptom exacerbation over the last three months based on the investigator's judgment
currently taking oral risperidone as maintenance therapy
Score of ≤ 4 (moderately ill at most) on the Clinical Global Impression - Severity of Illness (CGI-S)
If a sexually active female of childbearing potential, using a medically accepted method of birth control.

Who cannot join

Presence of an uncontrolled, unstable, clinically significant medical condition that in the opinion of the investigator could interfere with the interpretation of safety and PK evaluations
If female, a positive serum pregnancy test, or planning to become pregnant between signing informed consent and 1 month after the last dose of study drug or is breastfeeding a child.
History of neuroleptic malignant syndrome and current or past history of clinically significant tardive dyskinesia.
The participant has a primary diagnosis other than schizophrenia diagnosis that is primarily responsible for current symptoms and functional impairment
Positive test result for drugs of abuse or alcohol unless the positive finding can be accounted for by documented prescription use.
In the investigator's opinion, at imminent risk of committing self-harm or harm to others.

Show all 9Show fewer

Unwilling to discontinue any of the prohibited medications prior to the baseline visit or unable to safely washout such medication without significant destabilization or increased risk of self-harm (suicide).
Receipt study drug in another investigational study in the last 90 days.
Current participation in any other clinical trial.

Trial locations and contacts

1 site in 1 country.

Jordan1 site

Investigational Site
Amman

Other trials in Jordan

About this study

Official title: A Single Ascending Dose Phase 1 Study to Evaluate the Pharmacokinetics, Safety and Tolerability of a Single Intramuscular Injection of Quarterly Risperidone (QUAR) for Different Formulations and Dose Strengths in Participants With Schizophrenia (QUARTZ Study)

Read the detailed description

The study will assess the PK, safety and tolerability of QUAR when administered as a single IM injection, in patients with schizophrenia. The study will be conducted with 3 different dose strengths and up to two formulations.

After eligibility confirmation, an oral treatment period follow by a washout period will be performed before QUAR IM administration.

The different cohorts will be administered with one of the following dosages of Risperidone QUAR:

Cohort 1/2: Formulation 1 or 2. Dose level 1 (Gluteal); Cohort 1a/2a: Formulation 1 or 2. Dose level 2 (Gluteal); Cohort 1b/2b: Formulation 1 or 2. Dose level 3 (Gluteal); Cohort 1c/2c: Formulation 1 or 2. Dose level 3 (Deltoid);

The progression to the next cohorts will take place after a clinical safety assessment. Several blood samples for plasma pharmacokinetic (PK) assessments will be obtained pre-dose and post-dose. Safety assessments will be conducted at each pre-specified time points.

After assessment of Cohort 1 (formulation 1, Dose Level 1, -gluteus-) progression to the next cohort with same formulation and escalating dose will take place (Cohort 1a -gluteus-). After assessment of Cohort 1a, progression and randomization (gluteus/deltoid) to the next cohorts with same formulation and escalating dose will take place (Cohort 1b -gluteus- and Cohort 1c -deltoid-). In this scenario, none of the Cohorts 2 will be conducted.

If the assessment for Cohort 1 is not adequate, none of the subsequent Cohorts 1 (a/b/c) will be conducted and progression to the next cohort (Cohort 2) with different formulation and same level of dose as Cohort 1 will take place (Cohort 2: Formulation 2, Dose Level 1 -gluteus-). After assessment of Cohort 2, progression to the next cohort with same formulation and escalating dose will take place (Cohort 2a -gluteus-). After assessment of Cohort 2a, progression and randomization (gluteus/deltoid) to the next cohorts with same formulation and escalating dose will take place (Cohort 2b -gluteus- and Cohort 2c -deltoid-).

Conditions: Schizophrenia
Being tested: Oral risperidone; QUAR F1/2, Dose 1 - Gluteal, Oral risperidone; QUAR F1/2, Dose 2 - Gluteal, Oral risperidone; QUAR F1/2, Dose 3 - Gluteal, Oral risperidone; QUAR F1/2, Dose 3 - Deltoids
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oral risperidone; QUAR F1/2, Dose 1 - GlutealDrug
Dose level 1
Oral risperidone; QUAR F1/2, Dose 2 - GlutealDrug
Dose level 2
Oral risperidone; QUAR F1/2, Dose 3 - GlutealDrug
Dose level 3
Oral risperidone; QUAR F1/2, Dose 3 - DeltoidsDrug
Dose level 3

Study groups in NCT06276361
Study group	Role	What they receive
Cohort 1/2	Experimental	Patient will recieve oral risperidone for one week followed by a single IM injection of Risperidone QUAR out of two possible formulations (F1/F2) with a level 1 dose. Receives: Drug: Oral risperidone; QUAR F1/2, Dose 1 - Gluteal
Cohort 1a/2a	Experimental	Patient will recieve oral risperidone for one week followed by a single IM injection of Risperidone QUAR out of two possible formulations (F1/F2) with a level 2 dose. Receives: Drug: Oral risperidone; QUAR F1/2, Dose 2 - Gluteal
Cohort 1b//2b	Experimental	Patient will recieve oral risperidone for one week followed by a single IM injection of Risperidone QUAR out of two possible formulations (F1/F2) with a level 3 dose. Receives: Drug: Oral risperidone; QUAR F1/2, Dose 3 - Gluteal
Cohort 1c/2c	Experimental	Patient will recieve oral risperidone for one week followed by a single IM injection of Risperidone QUAR out of two possible formulations (F1/F2) with a level 3 dose. Receives: Drug: Oral risperidone; QUAR F1/2, Dose 3 - Deltoids

What is being measured

The primary outcome is the main question the study is designed to answer.

λz
Terminal elimination rate constant
Measured: Following Oral and QUAR administration until day 17 or 196 respectively
t1/2
Terminal elimination half-life
Measured: Following Oral and QUAR administration until day 17 or 196 respectively
Tmax
Time to peak concentration
Measured: Following Oral and QUAR administration until day 17 or 196 respectively
Cmax
Peak plasma concentration
Measured: Following Oral and QUAR administration until day 17 or 196 respectively
Cmin
Minimum plasma concentration
Measured: Following Oral and QUAR administration until day 17 or 196 respectively
Clast
Last observed plasma concentration
Measured: Following Oral and QUAR administration until day 17 or 196 respectively
AUC0-t
Area under the curve
Measured: Following Oral and QUAR administration until day 17 or 196 respectively
AUCinf
Area under the curve
Measured: Following QUAR administration until day 196
AUCextrap
Area under the curve
Measured: Following QUAR administration until day 196
Vd/F
Apparent volume of distribution
Measured: Following Oral and QUAR administration until day 17 or 196 respectively
Cl/F
Apparent total body clearance
Measured: Following Oral and QUAR administration until day 17 or 196 respectively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Sep 20237 Jul 2025

First posted26 Feb 2024
Study start26 Sep 2023
Primary completion7 Jul 2025
Study completion7 Jul 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for SchizophreniaStudies 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: Randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06276361
Sponsor's protocol ID: ROV-QUAR-2023-01
Acronym: QUARTZ
Status last verified: Sep 2025
First submitted: 16 Feb 2024
Last updated: 8 Sep 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Ascending Dose Phase 1 Study to Evaluate the Pharmacokinetics, Safety and Tolerability of a Single Intramuscular Injection of Quarterly Risperidone (QUAR) for Different Formulations and Dose Strengths in Participants With Schizophrenia (QUARTZ Study)
ClinicalTrials.gov ID: NCT06276361
Acronym / sponsor ID: QUARTZ / ROV-QUAR-2023-01
Conditions: Schizophrenia
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: Rovi Pharmaceuticals LaboratoriesIndustry (pharma, biotech, devices)
Study start: 26 Sep 2023 (actual)
Primary completion: 7 Jul 2025 (actual)
Study completion: 7 Jul 2025 (actual)
First posted: 26 Feb 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.

Detailed description

After eligibility confirmation, an oral treatment period follow by a washout period will be performed before QUAR IM administration.

The different cohorts will be administered with one of the following dosages of Risperidone QUAR:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Cohort 1/2	Experimental	Drug: Oral risperidone; QUAR F1/2, Dose 1 - GlutealPatient will recieve oral risperidone for one week followed by a single IM injection of Risperidone QUAR out of two possible formulations (F1/F2) with a level 1 dose.
Cohort 1a/2a	Experimental	Drug: Oral risperidone; QUAR F1/2, Dose 2 - GlutealPatient will recieve oral risperidone for one week followed by a single IM injection of Risperidone QUAR out of two possible formulations (F1/F2) with a level 2 dose.
Cohort 1b//2b	Experimental	Drug: Oral risperidone; QUAR F1/2, Dose 3 - GlutealPatient will recieve oral risperidone for one week followed by a single IM injection of Risperidone QUAR out of two possible formulations (F1/F2) with a level 3 dose.
Cohort 1c/2c	Experimental	Drug: Oral risperidone; QUAR F1/2, Dose 3 - DeltoidsPatient will recieve oral risperidone for one week followed by a single IM injection of Risperidone QUAR out of two possible formulations (F1/F2) with a level 3 dose.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Capable of providing informed consent.
Male or female aged ≥ 18 years to < 65 years with BMI ≥17.0 to ≤35.0 kg/m2
Current diagnosis of schizophrenia, according to the Diagnostic and DSM-5 criteria.
Medically stable over the last month, and psychiatrically stable without significant symptom exacerbation over the last three months based on the investigator's judgment
currently taking oral risperidone as maintenance therapy

Key exclusion criteria (9 listed)

Presence of an uncontrolled, unstable, clinically significant medical condition that in the opinion of the investigator could interfere with the interpretation of safety and PK evaluations
If female, a positive serum pregnancy test, or planning to become pregnant between signing informed consent and 1 month after the last dose of study drug or is breastfeeding a child.
History of neuroleptic malignant syndrome and current or past history of clinically significant tardive dyskinesia.
The participant has a primary diagnosis other than schizophrenia diagnosis that is primarily responsible for current symptoms and functional impairment
Positive test result for drugs of abuse or alcohol unless the positive finding can be accounted for by documented prescription use.

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
Oral risperidone; QUAR F1/2, Dose 1 - GlutealDose level 1	Drug	Cohort 1/2
Oral risperidone; QUAR F1/2, Dose 2 - GlutealDose level 2	Drug	Cohort 1a/2a
Oral risperidone; QUAR F1/2, Dose 3 - GlutealDose level 3	Drug	Cohort 1b//2b
Oral risperidone; QUAR F1/2, Dose 3 - DeltoidsDose level 3	Drug	Cohort 1c/2c

Primary outcome

λz
Time frame: Following Oral and QUAR administration until day 17 or 196 respectively
Terminal elimination rate constant
t1/2
Time frame: Following Oral and QUAR administration until day 17 or 196 respectively
Terminal elimination half-life
Tmax
Time frame: Following Oral and QUAR administration until day 17 or 196 respectively
Time to peak concentration
Cmax
Time frame: Following Oral and QUAR administration until day 17 or 196 respectively
Peak plasma concentration
Cmin
Time frame: Following Oral and QUAR administration until day 17 or 196 respectively
Minimum plasma concentration
Clast
Time frame: Following Oral and QUAR administration until day 17 or 196 respectively
Last observed plasma concentration
AUC0-t
Time frame: Following Oral and QUAR administration until day 17 or 196 respectively
Area under the curve
AUCinf
Time frame: Following QUAR administration until day 196
Area under the curve
AUCextrap
Time frame: Following QUAR administration until day 196
Area under the curve
Vd/F
Time frame: Following Oral and QUAR administration until day 17 or 196 respectively
Apparent volume of distribution
Cl/F
Time frame: Following Oral and QUAR administration until day 17 or 196 respectively
Apparent total body clearance

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 8 Sep 2025.

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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?

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 7 inclusion and 9 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 8 Sep 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 Jordan. 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?

λz (time frame: Following Oral and QUAR administration until day 17 or 196 respectively). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06276361.

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 8 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.