HealthyPhase 1NCT06600477
A Study of Olanzapine After Intranasal and Intramuscular Administration
A Phase 1 study testing olanzapine in people with Healthy, run by Neurelis, Inc. at 1 site in Jordan.
Trial summary
NRL-4, a nasal spray formulation of the atypical antipsychotic olanzapine is being developed by Neurelis Inc. for use as a rescue medication for acute episodes of agitation in schizophrenia, schizoaffective and bipolar I disorder. Also being tested are different concentrations of Intravail A3. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- olanzapine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteJordan
- Study dates
- 16 Oct 2023to 1 Nov 2023
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects aged 18 to 55 years, inclusive.
- Body weight ≥51 kg and ≤111 kg, and body mass index (BMI) range within 18 - 35 kg/m2.
- No clinically significant abnormal findings in the medical and surgical history, on the physical examination, vital sign measurements, electrocardiogram (ECG), or clinical laboratory results during Screening or Admission.
- Written informed consent to participate in the study.
- Capable of returning to study site for all study visits, including the initial confinement period, and willing to comply with all required study procedures.
- Non- or ex-smoker, with ex-smoker defined as someone who completely stopped smoking for at least 6 months before day 1 of the study.
- Sexually active males whose partners are females of childbearing potential must have agreed to use condoms from screening through at least 90 days after administration of study drug and ensured that female partner was using an acceptable form of contraception.
Who cannot join
- A history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, severe seasonal or non seasonal allergies, nasal polyps or any nasal passage abnormality that could interfere with nasal spray administration, or any other condition which, in the opinion of the Principal Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- Treatment with any known enzyme altering drugs such as barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to the first dose of study drug or during the entire study duration.
- Subjects who have been on an abnormal diet (such as one that severely restricts specific basic food groups [e.g., ketogenic diet], limits calories [e.g., fast], and/or requires the use of daily supplements as a substitute for the foods typically eaten at mealtimes), during the four (4) weeks preceding the study.
- Subjects who donated blood or plasma within 3 months of the first dose of study drug.
- Participation in a bioequivalence study or in a clinical trial with IP administration within 80 days prior to the first dose of study drug.
- Inadequate or difficult venous access that may jeopardize the quality or timing of the PK samples.
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- Use of any prescription or over the counter (OTC) medication within 30 days prior to the first dose of study drug or during the study.
- Positive blood screen for HIV, Hepatitis B surface antigen (HbSAg), or Hepatitis C, or a positive screen for alcohol or drugs of abuse.
- History of major depression or suicide attempt, or judged by the investigator as being at significant risk for suicide, violence, or homicide.
- History of postural orthostatic tachycardia syndrome or orthostatic hypotension.
Trial locations and contacts
1 site in 1 country.
Jordan1 site
International Pharmaceutical Research Center (IPRC) Clinical Site
Amman, Jordan
About this study
Official title: Comparative Randomized, Single Dose, Three-Arm, Parallel Open-Label Study to Characterize the Pharmacokinetics of 7.5 Mg Olanzapine Intranasal Spray and 7.5 Mg Olanzapine Intramuscular Injection After Administration to Healthy Male Adults Under Fasting Conditions
NRL-4, a nasal spray formulation of the atypical antipsychotic olanzapine is being developed by Neurelis Inc. for use as a rescue medication for acute episodes of agitation in schizophrenia, schizoaffective and bipolar I disorder. Also being tested are different concentrations of Intravail A3. Intravail A3 belongs to a class of nonionic surfactants known as alkylglycosides. Alkylglycosides have been extensively studied for their ability to promote increased bioavailability of drugs via the nasal, oral, and ocular routes.
In this study it will be tested if the olanzapine in the two Test products will show comparable pharmacokinetics, safety and tolerability in comparison to the Reference product through the primary pharmacokinetic parameters Cmax, AUC from time 0 to time t and AUC from time 0 to infinity, and safety assessments, including nasal irritation, sedation and pain scales.
- Conditions
- Healthy
- Being tested
- olanzapine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olanzapineDrug
7.5 mg
| Study group | Role | What they receive |
|---|---|---|
| 7.5 mg olanzapine per 100 µL with 0.25% Intravail A3 | Active comparator | 7.5 mg olanzapine per 100 µL with 0.25% Intravail A3 Receives: Drug: olanzapine |
| 7.5 mg olanzapine per 100 µL with 0.50% Intravail A3 | Active comparator | 7.5 mg olanzapine per 100 µL with 0.50% Intravail A3 Receives: Drug: olanzapine |
| olanzapine intramuscular injection | Active comparator | 7.5 mg olanzapine per 1.5 ml of reconstituted 5.0 mg/ml solution intramuscular injection Receives: Drug: olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
(1) Bioavailability of test products compared to reference product based on pharmacokinetic parameter of AUC from time 0 to time t
Characterize the pharmacokinetics of two Test Products (one product, A, is 7.5 mg olanzapine per 100 µL with 0.25% Intravail A3 as absorption enhancer and another product is, B, 7.5 mg olanzapine per 100 µL with 0.50% Intravail A3 as absorption enhancer via nasal spray) relative to Reference Product (C, intramuscular injection) after a single dose of 7.5 mg olanzapine to healthy male adults under fasting conditions.
Measured: 240 hours
Secondary outcomes (2)
(2) Bioavailability of test products compared to reference product based on pharmacokinetic parameter of Cmax
Characterize the pharmacokinetics of two Test Products (one product, A, is 7.5 mg olanzapine per 100 µL with 0.25% Intravail A3 as absorption enhancer and another product is, B, 7.5 mg olanzapine per 100 µL with 0.50% Intravail A3 as absorption enhancer via nasal spray) relative to Reference Product (C, intramuscular injection) after a single dose of 7.5 mg olanzapine to healthy male adults under fasting conditions.
Measured: 240 hours
(3) Bioavailability of test products compared to reference product based on pharmacokinetic parameter of AUC from time 0 to infinity
Characterize the pharmacokinetics of two Test Products (one product, A, is 7.5 mg olanzapine per 100 µL with 0.25% Intravail A3 as absorption enhancer and another product is, B, 7.5 mg olanzapine per 100 µL with 0.50% Intravail A3 as absorption enhancer via nasal spray) relative to Reference Product (C, intramuscular injection) after a single dose of 7.5 mg olanzapine to healthy male adults under fasting conditions.
Measured: 240 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start16 Oct 2023
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurelis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600477
- Sponsor's protocol ID
- OLA-1122-126
- Status last verified
- Aug 2024
- First submitted
- 6 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Madden S, Citrome L, Correll CU, Shih EK, Lopez-Toledano M, Rabinowicz AL, Carrazana E. A Single-Dose, Randomized, Open-Label, Parallel Design Study to Characterize the Pharmacokinetics of an Investigational Olanzapine Intranasal Spray Compared to a Reference Dose of Olanzapine Intramuscular Injection in Healthy Adult Males. J Clin Psychiatry. 2025 Mar 19;86(2):24m15665. doi: 10.4088/JCP.24m15665.
PubMed 40117564
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Randomized, Single Dose, Three-Arm, Parallel Open-Label Study to Characterize the Pharmacokinetics of 7.5 Mg Olanzapine Intranasal Spray and 7.5 Mg Olanzapine Intramuscular Injection After Administration to Healthy Male Adults Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT06600477
- Acronym / sponsor ID
- OLA-1122-126
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Neurelis, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 19 Sep 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.
NRL-4, a nasal spray formulation of the atypical antipsychotic olanzapine is being developed by Neurelis Inc. for use as a rescue medication for acute episodes of agitation in schizophrenia, schizoaffective and bipolar I disorder. Also being tested are different concentrations of Intravail A3. Intravail A3 belongs to a class of nonionic surfactants known as alkylglycosides. Alkylglycosides have been extensively studied for their ability to promote increased bioavailability of drugs via the nasal, oral, and ocular routes.
In this study it will be tested if the olanzapine in the two Test products will show comparable pharmacokinetics, safety and tolerability in comparison to the Reference product through the primary pharmacokinetic parameters Cmax, AUC from time 0 to time t and AUC from time 0 to infinity, and safety assessments, including nasal irritation, sedation and pain scales.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 7.5 mg olanzapine per 100 µL with 0.25% Intravail A3 | Active comparator | Drug: olanzapine7.5 mg olanzapine per 100 µL with 0.25% Intravail A3 |
| 7.5 mg olanzapine per 100 µL with 0.50% Intravail A3 | Active comparator | Drug: olanzapine7.5 mg olanzapine per 100 µL with 0.50% Intravail A3 |
| olanzapine intramuscular injection | Active comparator | Drug: olanzapine7.5 mg olanzapine per 1.5 ml of reconstituted 5.0 mg/ml solution intramuscular injection |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy male subjects aged 18 to 55 years, inclusive.
- Body weight ≥51 kg and ≤111 kg, and body mass index (BMI) range within 18 - 35 kg/m2.
- No clinically significant abnormal findings in the medical and surgical history, on the physical examination, vital sign measurements, electrocardiogram (ECG), or clinical laboratory results during Screening or Admission.
- Written informed consent to participate in the study.
- Capable of returning to study site for all study visits, including the initial confinement period, and willing to comply with all required study procedures.
Key exclusion criteria (10 listed)
- A history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, severe seasonal or non seasonal allergies, nasal polyps or any nasal passage abnormality that could interfere with nasal spray administration, or any other condition which, in the opinion of the Principal Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- Treatment with any known enzyme altering drugs such as barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to the first dose of study drug or during the entire study duration.
- Subjects who have been on an abnormal diet (such as one that severely restricts specific basic food groups [e.g., ketogenic diet], limits calories [e.g., fast], and/or requires the use of daily supplements as a substitute for the foods typically eaten at mealtimes), during the four (4) weeks preceding the study.
- Subjects who donated blood or plasma within 3 months of the first dose of study drug.
- Participation in a bioequivalence study or in a clinical trial with IP administration within 80 days prior to the first dose of study drug.
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 |
|---|---|---|
| olanzapine7.5 mg | Drug | 7.5 mg olanzapine per 100 µL with 0.25% Intravail A3, 7.5 mg olanzapine per 100 µL with 0.50% Intravail A3, olanzapine intramuscular injection |
Primary outcome
(1) Bioavailability of test products compared to reference product based on pharmacokinetic parameter of AUC from time 0 to time t
Time frame: 240 hours
Characterize the pharmacokinetics of two Test Products (one product, A, is 7.5 mg olanzapine per 100 µL with 0.25% Intravail A3 as absorption enhancer and another product is, B, 7.5 mg olanzapine per 100 µL with 0.50% Intravail A3 as absorption enhancer via nasal spray) relative to Reference Product (C, intramuscular injection) after a single dose of 7.5 mg olanzapine to healthy male adults under fasting conditions.
2 secondary outcomes
(2) Bioavailability of test products compared to reference product based on pharmacokinetic parameter of Cmax
Time frame: 240 hours
(3) Bioavailability of test products compared to reference product based on pharmacokinetic parameter of AUC from time 0 to infinity
Time frame: 240 hours
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 19 Sep 2024.
- Derived from this study: PubMed 40117564Madden S, Citrome L, Correll CU, Shih EK, Lopez-Toledano M, Rabinowicz AL, Carrazana E. A Single-Dose, Randomized, Open-Label, Parallel Design Study to Characterize the Pharmacokinetics of an Investigational Olanzapine Intranasal Spray Compared to a Reference Dose of Olanzapine Intramuscular Injection in Healthy Adult Males. J Clin Psychiatry. 2025 Mar 19;86(2):24m15665. doi: 10.4088/JCP.24m15665.
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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?
A Phase 1 study testing olanzapine in people with Healthy, run by Neurelis, Inc. at 1 site in Jordan.
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 10 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 19 Sep 2024. 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?
(1) Bioavailability of test products compared to reference product based on pharmacokinetic parameter of AUC from time 0 to time t (time frame: 240 hours). 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 NCT06600477, which also lists 1 linked publication.
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 19 Sep 2024.