Healthy VolunteersPhase 1NCT05264493
Bioavailability Study of Naloxone 5 Milligrams (mg) Intramuscular (IM) Autoinjector
A Phase 1 study testing NaxRedy ™ and Naloxone Hydrochloride Injection, USP in people with Healthy Volunteers, run by Pfizer at 1 site in United States.
Trial summary
To compare the plasma concentration (bioavailability) and safety of a single naloxone 5 mg autoinjector intramuscular (IM) injection to a single 2 mg IM injection (an approved safe dose) and to a single 2 mg bolus intravenous (IV) injection (an approved safe dose) Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- NaxRedy ™ and Naloxone Hydrochloride Injection, USP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2020to 8 Jan 2021
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Age and Sex:
- Healthy male and/or female participants of non-childbearing potential, who, at the time of screening, are between the ages of 18 and 55 years, inclusive.
- Refer to protocol for reproductive criteria for male and female participants.
- Type of Participant and Disease Characteristics:
- Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs, 12-lead ECG, and/or clinical laboratory tests.
Show all 12Show fewer
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- Weight:
- BMI of 17.5 to 30.5 kg/m2; and a total body weight > 50 kg (110 lb).
- Informed Consent:
- 5. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
- -
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- Medical Conditions:
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Current or past diagnosis of any type of drug dependence within the past year will not be eligible to participate. History of alcohol abuse, dependence or binge drinking and/or any other illicit drug use within 6 months of screening. Binge drinking is hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% spirit or 3 ounces (90 mL) of wine).
- If fever is present within 7 days of admission or screening.
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
Show all 26Show fewer
- History of HIV infection, hepatitis B, or hepatitis C, positive testing for HIV, HBsAg, or HCVAb. Hepatitis B vaccination is allowed.
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Prior/Concomitant Therapy:
- Use of prescription or nonprescription drugs and dietary and herbal supplements within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention. Prior/Concurrent Clinical Study Experience:
- Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
- Diagnostic Assessments:
- A positive urine drug test.
- Has participated in, is currently participating in, or is seeking treatment for substance-and/or alcohol-related disorders (excluding nicotine and caffeine).
- Has a positive alcohol breathalyzer test at screening or upon admission to the study center of Treatment Period. Positive results may be repeated and/or participants re-scheduled at the investigator's discretions.
- Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest. If BP is ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility. Repeated BP tests should be spaced at least 5 minutes apart.
- Screening supine 12-lead ECG demonstrating a QTc interval > 450 msec or a QRS interval > 120 msec. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the participant's eligibility.
- Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary:
- Abnormal platelet count and/or PT/INR; AST or ALT level ≥1.5 × ULN; Total bilirubin level ≥1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN.
- Other Exclusions:
- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol.
- History of hypersensitivity to naloxone or any of the components in the formulation of the study products.
- Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
New Haven Clinical Research Unit
New Haven, Connecticut, 06511
About this study
Official title: A PHASE 1 RANDOMIZED, OPEN-LABEL, SINGLE-DOSE, 3-TREATMENT CROSS-OVER STUDY TO EVALUATE RELATIVE BIOAVAILABILITY OF INTRAMUSCULAR INJECTION OF NALOXONE HCL 5 Milligrams (mg) [5mg/0.5 Milliliters (mL] USING A QUICKSHOT™ AUTOINJECTOR COMPARED TO 2 mg NALOXONE INTRAMUSCULAR INJECTION AND 2 mg NALOXONE INTRAVENOUS INJECTION IN HEALTHY ADULT PARTICIPANTS
To compare the plasma concentration (bioavailability) and safety of a single naloxone 5 mg autoinjector intramuscular (IM) injection to a single 2 mg IM injection (an approved safe dose) and to a single 2 mg bolus intravenous (IV) injection (an approved safe dose)
Read the detailed description
A randomized, open-label, 3-treatment, 6-sequences, 3-period Williams Square crossover single-dose, relative bioavailability study in healthy adult participants. The study includes Screening period, a Treatment period and a Follow-up contact (SoA). At least twelve (12) participants will be enrolled. If the number of evaluable participants falls below 12, participants may be replaced.
- Conditions
- Healthy Volunteers
- Being tested
- NaxRedy ™, Naloxone Hydrochloride Injection, USP
- Keywords
- naloxone, autoinjector, intramuscular, high dose, 5 mg, healthy volunteers, safety, cross-over study, pharmacokinetics, 3 treatment arms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaxRedy ™Drug
5 mg (5 mg/0.5 mL) IM autoinjector injection into lateral thigh
Naloxone Hydrochloride Injection, USPDrug
2 mg IM (2mg/2 mL) injection into gluteal muscle
Naloxone Hydrochloride Injection, USPDrug
2 mg bolus IV (2mg/2 mL)
| Study group | Role | What they receive |
|---|---|---|
| naloxone 5 mg IM autoinjector | Experimental | participants will receive in random order, a single naloxone 5 mg IM autoinjector injection into the lateral thigh Receives: Drug: NaxRedy ™ |
| naloxone 2 mg IM | Active comparator | participants will receive in random order, a single naloxone 2 mg IM injection into the gluteus muscle Receives: Drug: Naloxone Hydrochloride Injection, USP |
| naloxone 2mg bolus IV | Active comparator | participants will receive in random order, a single naloxone 2 mg bolus IV injection Receives: Drug: Naloxone Hydrochloride Injection, USP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma naloxone concentration (Cmax) of a single 5 mg IM autoinjector injection compared to a 2 mg IM injection
Comparison of bioavailability
Measured: predose, 2.5, 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 360, 480, and 1440 minutes after dose
Area under the naloxone concentration versus time curve (AUC) from time zero to the last collection time (AUClast) of a single 5 mg IM autoinjector injection compared to a 2 mg IM injection
Comparison of bioavailability
Measured: predose, 2.5, 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 360, 480, and 1440 minutes after dose
Secondary outcomes (11)
AUC from time zero to 2.5 minutes (AUC0-2.5)
Pharmacokinetics all treatment arms
Measured: predose and 2.5 minutes after dose
AUC from time zero to 5 minutes (AUC0-5)
Pharmacokinetics all treatment arms
Measured: predose, 2.5 and 5 minutes after dose
AUC from time zero to 15 minutes (AUC0-15)
Pharmacokinetics all treatment arms
Measured: predose, 2.5, 5, 10 and 15 minutes after dose
AUC from time zero to 30 minutes (AUC0-30)
Pharmacokinetics all treatment arms
Measured: predose, 2.5, 5, 10, 15, and 30 minutes after dose
AUC from time zero extrapolated to infinity (AUCinf) [if data permit]
Pharmacokinetics all treatment arms
Measured: predose, 2.5, 5, 10, 15, 30, 60,90, 120, 180, 240, 360, 480, 1440 minutes after dose
Time to maximum observed naloxone plasma concentration (Tmax) [if data permit],
Pharmacokinetics all treatment arms
Measured: predose, 2.5, 5, 10, 15, 30, 60,90, 120, 180, 240, 360, 480, 1440 minutes after dose
Time for naloxone plasma concentration to decrease by one half (t1/2) [if data permit].
Pharmacokinetics all treatment arms
Measured: predose, 2.5, 5, 10, 15, 30, 60,90, 120, 180, 240, 360, 480, 1440 minutes after dose
Number of participants with a clinically significant change from baseline physical examination
Safety and tolerability all treatments
Measured: baseline to 28 days after last dose
Number of participants with a clinically significant change from baseline vital signs
Safety and tolerability all treatments
Measured: baseline to 28 days after last dose
Number of participants with a clinically significant change from baseline clinical safety laboratory measurements
Safety and tolerability all treatment arms
Measured: baseline to 28 days after last dose
Number of participants with clinically significant AEs from baseline
Safety and tolerability all treatment arms
Measured: baseline to 28 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start6 Oct 2020
- Primary completion8 Jan 2021
- Study completion8 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Williams Square Study Design with 6 sequences
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264493
- Sponsor's protocol ID
- C2431001
- Status last verified
- Mar 2022
- First submitted
- 14 Feb 2022
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1 RANDOMIZED, OPEN-LABEL, SINGLE-DOSE, 3-TREATMENT CROSS-OVER STUDY TO EVALUATE RELATIVE BIOAVAILABILITY OF INTRAMUSCULAR INJECTION OF NALOXONE HCL 5 Milligrams (mg) [5mg/0.5 Milliliters (mL] USING A QUICKSHOT™ AUTOINJECTOR COMPARED TO 2 mg NALOXONE INTRAMUSCULAR INJECTION AND 2 mg NALOXONE INTRAVENOUS INJECTION IN HEALTHY ADULT PARTICIPANTS
- ClinicalTrials.gov ID
- NCT05264493
- Acronym / sponsor ID
- C2431001
- Conditions
- Healthy Volunteers
- Keywords
- naloxone, autoinjector, intramuscular, high dose, 5 mg, healthy volunteers, safety, cross-over study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 6 Oct 2020 (actual)
- Primary completion
- 8 Jan 2021 (actual)
- Study completion
- 8 Jan 2021 (actual)
- First posted
- 3 Mar 2022 (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.
To compare the plasma concentration (bioavailability) and safety of a single naloxone 5 mg autoinjector intramuscular (IM) injection to a single 2 mg IM injection (an approved safe dose) and to a single 2 mg bolus intravenous (IV) injection (an approved safe dose)
Detailed description
A randomized, open-label, 3-treatment, 6-sequences, 3-period Williams Square crossover single-dose, relative bioavailability study in healthy adult participants. The study includes Screening period, a Treatment period and a Follow-up contact (SoA). At least twelve (12) participants will be enrolled. If the number of evaluable participants falls below 12, participants may be replaced.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Williams Square Study Design with 6 sequences
| Arm | Type | Receives |
|---|---|---|
| naloxone 5 mg IM autoinjector | Experimental | Drug: NaxRedy ™participants will receive in random order, a single naloxone 5 mg IM autoinjector injection into the lateral thigh |
| naloxone 2 mg IM | Active comparator | Drug: Naloxone Hydrochloride Injection, USPparticipants will receive in random order, a single naloxone 2 mg IM injection into the gluteus muscle |
| naloxone 2mg bolus IV | Active comparator | Drug: Naloxone Hydrochloride Injection, USPparticipants will receive in random order, a single naloxone 2 mg bolus IV injection |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Healthy male and/or female participants of non-childbearing potential, who, at the time of screening, are between the ages of 18 and 55 years, inclusive.
- Refer to protocol for reproductive criteria for male and female participants.
- Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs, 12-lead ECG, and/or clinical laboratory tests.
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Key exclusion criteria (26 listed)
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Current or past diagnosis of any type of drug dependence within the past year will not be eligible to participate. History of alcohol abuse, dependence or binge drinking and/or any other illicit drug use within 6 months of screening. Binge drinking is hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% spirit or 3 ounces (90 mL) of wine).
- If fever is present within 7 days of admission or screening.
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- History of HIV infection, hepatitis B, or hepatitis C, positive testing for HIV, HBsAg, or HCVAb. Hepatitis B vaccination is allowed.
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 |
|---|---|---|
| NaxRedy ™5 mg (5 mg/0.5 mL) IM autoinjector injection into lateral thigh | Drug | naloxone 5 mg IM autoinjector |
| Naloxone Hydrochloride Injection, USP2 mg IM (2mg/2 mL) injection into gluteal muscle | Drug | naloxone 2 mg IM |
| Naloxone Hydrochloride Injection, USP2 mg bolus IV (2mg/2 mL) | Drug | naloxone 2mg bolus IV |
Primary outcome
Maximum observed plasma naloxone concentration (Cmax) of a single 5 mg IM autoinjector injection compared to a 2 mg IM injection
Time frame: predose, 2.5, 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 360, 480, and 1440 minutes after dose
Comparison of bioavailability
Area under the naloxone concentration versus time curve (AUC) from time zero to the last collection time (AUClast) of a single 5 mg IM autoinjector injection compared to a 2 mg IM injection
Time frame: predose, 2.5, 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 360, 480, and 1440 minutes after dose
Comparison of bioavailability
11 secondary outcomes
AUC from time zero to 2.5 minutes (AUC0-2.5)
Time frame: predose and 2.5 minutes after dose
AUC from time zero to 5 minutes (AUC0-5)
Time frame: predose, 2.5 and 5 minutes after dose
AUC from time zero to 15 minutes (AUC0-15)
Time frame: predose, 2.5, 5, 10 and 15 minutes after dose
AUC from time zero to 30 minutes (AUC0-30)
Time frame: predose, 2.5, 5, 10, 15, and 30 minutes after dose
AUC from time zero extrapolated to infinity (AUCinf) [if data permit]
Time frame: predose, 2.5, 5, 10, 15, 30, 60,90, 120, 180, 240, 360, 480, 1440 minutes after dose
Time to maximum observed naloxone plasma concentration (Tmax) [if data permit],
Time frame: predose, 2.5, 5, 10, 15, 30, 60,90, 120, 180, 240, 360, 480, 1440 minutes after dose
Time for naloxone plasma concentration to decrease by one half (t1/2) [if data permit].
Time frame: predose, 2.5, 5, 10, 15, 30, 60,90, 120, 180, 240, 360, 480, 1440 minutes after dose
Number of participants with a clinically significant change from baseline physical examination
Time frame: baseline to 28 days after last dose
Number of participants with a clinically significant change from baseline vital signs
Time frame: baseline to 28 days after last dose
Number of participants with a clinically significant change from baseline clinical safety laboratory measurements
Time frame: baseline to 28 days after last dose
Number of participants with clinically significant AEs from baseline
Time frame: baseline to 28 days after last dose
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 3 Mar 2022.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Screening Protocol
Pain
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.
Pfizer CT.gov Call Center study director
Pfizer
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 NaxRedy ™ and Naloxone Hydrochloride Injection, USP in people with Healthy Volunteers, run by Pfizer at 1 site in United States.
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 12 inclusion and 26 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 3 Mar 2022. 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 United States. 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?
Maximum observed plasma naloxone concentration (Cmax) of a single 5 mg IM autoinjector injection compared to a 2 mg IM injection (time frame: predose, 2.5, 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 360, 480, and 1440 minutes after dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2022.