Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06276361
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-02-16
Brief Title:
Pharmacokinetics Safety and Tolerability of Different Formulations and Dose Strengths of Quarterly Risperidone QUAR in Patients With Schizophrenia
Sponsor:
Rovi Pharmaceuticals Laboratories
Organization:
Rovi Pharmaceuticals Laboratories
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
QUARTZ
Brief 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
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 12 Formulation 1 or 2 Dose level 1 Gluteal Cohort 1a2a Formulation 1 or 2 Dose level 2 Gluteal Cohort 1b2b Formulation 1 or 2 Dose level 3 Gluteal Cohort 1c2c 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 gluteusdeltoid 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 abc 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 gluteusdeltoid to the next cohorts with same formulation and escalating dose will take place Cohort 2b -gluteus- and Cohort 2c -deltoid-
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 12 Formulation 1 or 2 Dose level 1 Gluteal Cohort 1a2a Formulation 1 or 2 Dose level 2 Gluteal Cohort 1b2b Formulation 1 or 2 Dose level 3 Gluteal Cohort 1c2c 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 gluteusdeltoid 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 abc 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 gluteusdeltoid to the next cohorts with same formulation and escalating dose will take place Cohort 2b -gluteus- and Cohort 2c -deltoid-
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None