A Phase 1 interventional study of Treatment A: Naloxone Nasal Spray and Treatment B: Naloxone Nasal Spray in Healthy Volunteer, sponsored by INSYS Therapeutics Inc. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-01.
Sponsored by INSYS Therapeutics Inc · Phase 1, Interventional, and Treatment
The main objective of this study is to compare early exposures of two test formulations of Naloxone Nasal Spray with the reference formulation of Naloxone HCl IM Injection under fasted conditions.
INSYS Therapeutics Inc is the lead sponsor of 45 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received Treatment A on Day 1 of Period 1, Treatment B on Day 1 of Period 2, and Treatment C on Day 1 of Period 3.
Drug: Treatment A: Naloxone Nasal Spray · Drug: Treatment B: Naloxone Nasal Spray · Drug: Treatment C: Naloxone HCL Intramuscular (IM) Injection
Participants received Treatment B on Day 1 of Period 1, Treatment C on Day 1 of Period 2, and Treatment A on Day 1 of Period 3.
Drug: Treatment A: Naloxone Nasal Spray · Drug: Treatment B: Naloxone Nasal Spray · Drug: Treatment C: Naloxone HCL Intramuscular (IM) Injection
Participants received Treatment C on Day 1 of Period 1, Treatment A on Day 1 of Period 2, and Treatment B on Day 1 of Period 3.
Drug: Treatment A: Naloxone Nasal Spray · Drug: Treatment B: Naloxone Nasal Spray · Drug: Treatment C: Naloxone HCL Intramuscular (IM) Injection
Participants received Treatment A on Day 1 of Period 1, Treatment C on Day 1 of Period 2, and Treatment B on Day 1 of Period 3.
Drug: Treatment A: Naloxone Nasal Spray · Drug: Treatment B: Naloxone Nasal Spray · Drug: Treatment C: Naloxone HCL Intramuscular (IM) Injection
Participants received Treatment C on Day 1 of Period 1, Treatment B on Day 1 of Period 2, and Treatment A on Day 1 of Period 3.
Drug: Treatment A: Naloxone Nasal Spray · Drug: Treatment B: Naloxone Nasal Spray · Drug: Treatment C: Naloxone HCL Intramuscular (IM) Injection
Participants received Treatment B on Day 1 of Period 1, Treatment A on Day 1 of Period 2, and Treatment C on Day 1 of Period 3.
Drug: Treatment A: Naloxone Nasal Spray · Drug: Treatment B: Naloxone Nasal Spray · Drug: Treatment C: Naloxone HCL Intramuscular (IM) Injection
Participants received naloxone nasal spray following a 10 hour fast.
Participants received naloxone nasal spray following a 10 hour fast.
Participants received naloxone HCl IM injection following a 10 hour fast.
Plasma Concentration of Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 1 hour post-dose
Partial Area Under the Concentration Curve (AUC) of Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 1 hour post-dose
Area Under the Curve from Time 0 to the Last Measured Concentration (AUC0-t) of Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 24 hours post-dose
Area Under the Curve from Time 0 to Infinity (AUC0-inf) of Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 24 hours post-dose
Percentage of AUC0-inf Obtained by Extrapolation (AUCextrap) of Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 24 hours post-dose
Maximum Plasma Concentration (Cmax) of Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 24 hours post-dose
Time to Reach Maximum Plasma Concentration (Tmax) of Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 24 hours post-dose
Last Quantifiable Concentration (Clast) of Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 24 hours post-dose
Time of the Last Quantifiable Concentration (Tlast) of Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 24 hours post-dose
Time Prior to the First Measurable (Non-Zero) Concentration (Tlag) of Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 24 hours post-dose
Elimination Rate Constant (λz) of Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 24 hours post-dose
Elimination Half-Life (t1/2) of Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 24 hours post-dose
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product during the course of a clinical investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not thought to be related to the investigational product. A serious AE (SAE) is any AE that results in death, is life threatening, requires hospitalization or prolongs existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is medically significant or requires intervention.
Time frame: Day 1 up to Day 10
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Naloxone