A placebo and comparator controlled phase 1, safety and tolerability study of 3 ascending doses of INP105 (intranasal OLZ by I231 POD® device).
A Phase 1, Randomized, Double-Blind, Placebo- and Active-Controlled, Single-Ascending-Dose, 2-Way, Incomplete Block, 2-Period Crossover, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of 3 Doses of INP105 (olanzapine delivered by I231 POD® Device) Nasal Spray in Healthy Volunteers
Clinical Network Services (CNS) Pty Ltd
36 participants
Aug 6, 2018
Interventional
Conditions
Summary
This research project is designed to test the safety, tolerability, pharmacokinetics (how the body processes the study drug) and pharmacodynamics (how the drug affects to body) of INP105. INP105 is a drug-device combination product; the drug is OLZ (Olanzapine); the device is the I231 Precision Olfactory Delivery (POD) device, which is a novel nasal (nose) spray. Approximately 36 participants in general good health (with a minimum of 9 males and 9 females) will be enrolled and will be allocated to receive 2 treatments across 2 treatment periods. In the first treatment period participants will have an equal change of receiving 1 of 3 reference drugs: IM 5 mg Zyprexa, IM 10 mg Zyprexa or Oral Wafer 10mg Zypreza Zydis. In treatment period 2, participants will be allocated to receive either INP105 or placebo in a 3:1 ratio. The dose strength of INP105 (5, 10 to 20 mg) will depend on the cohort the participant is assigned.
Eligibility
Inclusion Criteria6
- 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;
- Body mass index (BMI) between 18 and 32 kg/m2 inclusive;
- Negative urine drug screen/alcohol breath test at Screening and Day -1;
- The ability and willingness to attend the necessary visits at the study centre;
- Written informed consent signed prior to entry into the study;
- 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 Criteria17
- Known hypersensitivity to Zyprexa IM, Zyprexa Zydis or any of the ingredients in them or in INP105 or the placebo;
- Recently (within 3 months) or currently taking Zyprexa (any formulation);
- 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;
- A medical history of hypotension or currently taking anti-hypertensives at Screening or throughout the study.
- Current or recent smokers (< 3 months since quitting); inadvertent one-off smokers and social smokers will also be excluded;
- Females who are pregnant or lactating;
- 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;
- Abnormal and clinically significant laboratory tests;
- History or presence of alcohol or drug abuse within the 2 years prior to the first IP administration;
- Blood donation or significant blood loss within 60 days prior to the first IP administration;
- Plasma donation within 7 days prior to the first IP administration;
- Administration of IP in another trial within 30 days or 5 half-lives (whichever is longer) prior to the first IP administration;
- Significant surgery within the past 3 months prior to the first IP administration determined by the Investigator to be clinically relevant;
- Failure to satisfy the Investigator of fitness to participate for any other reason;
- 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;
- Any nasal congestion, deviated septum or physical blockage in either nostril;
- Positive for HIV, Hepatitis B or Hepatitis C.
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Interventions
Phase 1 trial to compare the safety, tolerability, PK and PD of 3 single ascending doses (SAD) of INP105 against 2 doses of intramuscular Zyprexa (5 mg or 10 mg) or 1 dose of oral Zyprexa Zydis (10 mg). 36 healthy volunteers (participants), male and female, 18-55 years will be enrolled in the study into 3 cohorts of 12. Each cohort will have 2 treatment periods with a 14-day wash-out in between. The treatments are as follows: Treatment Period 1: Participants will be assigned to Cohort 1, 2 or 3 and in each of these three cohorts, participants will have an equal chance of being treated with one of the three following treatments: intramuscular 5 mg Zyprexa, intramuscular 10 mg Zyprexa or Oral Wafer 10mg Zypreza Zydis, followed by a 14-day wash-out period. Treatment Period 2: Participants will return to the clinic and depending on the cohort (1, 2 or 3) they are enrolled in during period 1, they will be randomised to receive the following via I231 POD® nasal spray: Cohort 1: INP105 (5.0 mg OLZ) n=9 or Placebo n=3 Cohort 2: INP105 (10.0 mg OLZ) n=9 or Placebo n=3 Cohort 3: INP105 (20.0 mg OLZ) n=9 or Placebo n=3 All participants will be trained on the treatment delivery methods and clinic staff will observe all dosing activity.
Locations(1)
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ACTRN12618000966291