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

Last updated: July 8, 2024
Sponsor: Rovi Pharmaceuticals Laboratories
Overall Status: Active - Recruiting

Phase

1

Condition

Tourette's Syndrome

Post-traumatic Stress Disorders

Schizotypal Personality Disorder (Spd)

Treatment

Oral risperidone; QUAR F1/2, Dose 1 - Gluteal

Oral risperidone; QUAR F1/2, Dose 2 - Gluteal

Oral risperidone; QUAR F1/2, Dose 3 - Gluteal

Clinical Study ID

NCT06276361
ROV-QUAR-2023-01
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 significantsymptom 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 - Severityof Illness (CGI-S)

  • If a sexually active female of childbearing potential, using a medically acceptedmethod of birth control.

Exclusion

Exclusion Criteria:

  • Presence of an uncontrolled, unstable, clinically significant medical condition thatin the opinion of the investigator could interfere with the interpretation of safetyand PK evaluations

  • If female, a positive serum pregnancy test, or planning to become pregnant betweensigning informed consent and 1 month after the last dose of study drug or isbreastfeeding a child.

  • History of neuroleptic malignant syndrome and current or past history of clinicallysignificant tardive dyskinesia.

  • The participant has a primary diagnosis other than schizophrenia diagnosis that isprimarily responsible for current symptoms and functional impairment

  • Positive test result for drugs of abuse or alcohol unless the positive finding canbe accounted for by documented prescription use.

  • In the investigator's opinion, at imminent risk of committing self-harm or harm toothers.

  • Unwilling to discontinue any of the prohibited medications prior to the baselinevisit or unable to safely washout such medication without significantdestabilization 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.

Study Design

Total Participants: 100
Treatment Group(s): 4
Primary Treatment: Oral risperidone; QUAR F1/2, Dose 1 - Gluteal
Phase: 1
Study Start date:
September 26, 2023
Estimated Completion Date:
May 31, 2026

Study 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-).

Connect with a study center

  • Investigational Site

    Amman,
    Jordan

    Active - Recruiting

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