CompletedPhase 1

Pharmacokinetics (PK) and Safety of Multiple Doses of Intranasal Naloxone in Healthy Adults

United States24 participantsStarted 2022-03-28

Plain-language summary

This study will be a Phase 1, single-center, open-label, randomized cross-over study to evaluate the PK of a new AP003 device which delivers two sprays of 4 mg naloxone hydrochloride intranasally.

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Have a negative pregnancy test at Screening (serum pregnancy test) and before dosing at Day -1 (urine pregnancy test)
✓. Female subjects of non-childbearing potential must be:
✓. Women of childbearing potential who are not planning to be pregnant during the study period and who are using one of the following effective methods of contraception during the study period and for at least 30 days after last study visit:

Exclusion criteria

✕. alcohol abuse (regularly drinks more than 14 units of alcohol per week; 1 unit = 360 mL of beer, 150 mL of wine, or 45 mL of spirit \[40% a/v\]) or history of alcohol abuse within 6 months prior to Screening
✕. positive for recent alcohol use (by breathalyzer) at Screening or Baseline (Day -1)
✕. a history or evidence of abuse of licit or illicit drug substances or a positive urine drug screen (a urine sample was obtained for testing to determine the presence or absence of Schedule 1 or Schedule 2 typical drugs of abuse or their metabolites, including opioids, amphetamine derivatives, cocaine, and other analytes as needed) or drugs of abuse prior to Screening. History of cannabinoid use within 1 year prior to Screening or any current evidence of abuse.
✕. use of tobacco-containing products or had a history of tobacco use within 1 year prior to the screening visit
✕. use of e-cigarettes and/or nicotine replacement products or had used these products within 1 year prior to the screening visit.

What they're measuring

Mean naloxone plasma concentration AP003 dosing periods.

Timeframe: PK samples taken at various timepoints over the course of Pre-dose and post-dose for 12 hours.

Mean naloxone plasma concentration Narcan dosing periods

Timeframe: PK samples taken at various timepoints over the course of Pre-dose and post-dose for 12 hours.

Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAE)

Timeframe: Through end of study visit (within 7 days after second dose)

Incidence of abnormal vital signs

Timeframe: Through end of study visit (within 7 days after second dose)

Incidence of clinically significant ECG

Timeframe: Through end of study visit (within 7 days after second dose)

Incidence of clinical laboratory changes

Timeframe: Through end of study visit (within 7 days after second dose)

Incidence of adverse events of special interest (AESI) indicating of nasal irritation

Timeframe: Through end of study visit (within 7 days after second dose)

Trial details

NCT IDNCT05377255

SponsorEmergent BioSolutions

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-05-10

View on ClinicalTrials.gov More Opioid Overdose trials

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Have a negative pregnancy test at Screening (serum pregnancy test) and before dosing at Day -1 (urine pregnancy test)
✓. Female subjects of non-childbearing potential must be:
✓. Women of childbearing potential who are not planning to be pregnant during the study period and who are using one of the following effective methods of contraception during the study period and for at least 30 days after last study visit:

Exclusion criteria

✕. alcohol abuse (regularly drinks more than 14 units of alcohol per week; 1 unit = 360 mL of beer, 150 mL of wine, or 45 mL of spirit \[40% a/v\]) or history of alcohol abuse within 6 months prior to Screening
✕. positive for recent alcohol use (by breathalyzer) at Screening or Baseline (Day -1)
✕. a history or evidence of abuse of licit or illicit drug substances or a positive urine drug screen (a urine sample was obtained for testing to determine the presence or absence of Schedule 1 or Schedule 2 typical drugs of abuse or their metabolites, including opioids, amphetamine derivatives, cocaine, and other analytes as needed) or drugs of abuse prior to Screening. History of cannabinoid use within 1 year prior to Screening or any current evidence of abuse.
✕. use of tobacco-containing products or had a history of tobacco use within 1 year prior to the screening visit
✕. use of e-cigarettes and/or nicotine replacement products or had used these products within 1 year prior to the screening visit.

What they're measuring

Mean naloxone plasma concentration AP003 dosing periods.

Timeframe: PK samples taken at various timepoints over the course of Pre-dose and post-dose for 12 hours.

Mean naloxone plasma concentration Narcan dosing periods

Timeframe: PK samples taken at various timepoints over the course of Pre-dose and post-dose for 12 hours.

Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAE)

Timeframe: Through end of study visit (within 7 days after second dose)

Incidence of abnormal vital signs

Timeframe: Through end of study visit (within 7 days after second dose)

Incidence of clinically significant ECG

Timeframe: Through end of study visit (within 7 days after second dose)

Incidence of clinical laboratory changes

Timeframe: Through end of study visit (within 7 days after second dose)

Incidence of adverse events of special interest (AESI) indicating of nasal irritation

Timeframe: Through end of study visit (within 7 days after second dose)