A placebo and comparator controlled phase 1, safety and tolerability study of 3 ascending doses of INP105 (intranasal OLZ by I231 POD® device).

Phase 1

Completed

• Conditions: Acute Agitation in Schizophrenia; Acute Agitation in Bipolar I Disorder; Neurological - Other neurological disorders; Mental Health - Schizophrenia

• Registration Number: ACTRN12618000966291
• Lead Sponsor: Clinical Network Services (CNS) Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-07
• Study Completion: 2018-10-03
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1) In good general health, with no significant medical history and no clinically significant abnormalities on physical examination at Screening or before first dose of IP;
2) Body mass index (BMI) between 18 and 32 kg/m2 inclusive;
3) Negative urine drug screen/alcohol breath test at Screening and Day -1;
4) The ability and willingness to attend the necessary visits at the study centre;
5) Written informed consent signed prior to entry into the study;
6) Female subjects of childbearing potential, and male subjects and their partners, must agree to use adequate contraception, defined as complete abstinence, documented evidence of surgical sterilization or condom plus approved contraceptive method.

Exclusion Criteria

1) Known hypersensitivity to Zyprexa IM, Zyprexa Zydis or any of the ingredients in them or in INP105 or the placebo;
2) Recently (within 3 months) or currently taking Zyprexa (any formulation);
3) Participants taking medications known to inhibit or induce CYP1A2 at any time during the study period, and any participants taking prescription medications, over the counter medications or supplements that, in the opinion of the Investigator, may impact the subject’s response to olanzapine or impact the subject’s participation in the study. Oral contraceptives are permitted;
4) A medical history of hypotension or currently taking anti-hypertensives at Screening or throughout the study.
5) Current or recent smokers (< 3 months since quitting); inadvertent one-off smokers and social smokers will also be excluded;
6) Females who are pregnant or lactating;
7) Any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the subject will comply with the study;
8) Abnormal and clinically significant laboratory tests;
9) History or presence of alcohol or drug abuse within the 2 years prior to the first IP administration;
10) Blood donation or significant blood loss within 60 days prior to the first IP administration;
11) Plasma donation within 7 days prior to the first IP administration;
12) Administration of IP in another trial within 30 days or 5 half-lives (whichever is longer) prior to the first IP administration;
13) Significant surgery within the past 3 months prior to the first IP administration determined by the Investigator to be clinically relevant;
14) Failure to satisfy the Investigator of fitness to participate for any other reason;
15) Acute illness within 30 days prior to Day 1. Minor viral illnesses within 30 days prior to Day 1 may be randomized if all symptoms are resolved by admission and at the discretion of the Investigator;
16) Any nasal congestion, deviated septum or physical blockage in either nostril;
17) Positive for HIV, Hepatitis B or Hepatitis C.

Study & Design

• Study Type: Interventional
• Study Design: Not specified