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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02750748
Other study ID # Naltexone-Ph1a-002
Secondary ID
Status Completed
Phase Phase 1
First received April 21, 2016
Last updated January 11, 2017
Start date July 2016
Est. completion date September 2016

Study information

Verified date October 2016
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To determine the pharmacokinetics of 2 intranasal doses and 1 oral dose of naltrexone compared to an intramuscular dose of naltrexone.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- Males and females 18 to 55 years of age, inclusive.

- Provide written informed consent.

- BMI ranging from 18 to 30 kg/m2, inclusive.

- Adequate venous access.

- No clinically significant concurrent medical conditions determined by medical history, physical examination, clinical laboratory examination, vital signs, and 12-lead ECG.

- Male subjects must agree to use an acceptable method of contraception with female partners as well as not to donate sperm throughout the study and for 90 days after the last study drug administration. Female subject of childbearing potential must agree to use an acceptable method of birth control throughout the study and for 30 days after the last study drug administration. Oral contraceptives are prohibited.

- Agree not to ingest alcohol, drinks containing xanthine >500 mg/day (e.g., Coca Cola®, coffee, tea, etc.), or grapefruit/grapefruit juice.

- Participate in strenuous exercise 72 hours prior to admission through the last blood draw of the study.

Exclusion Criteria:

- Please contact site for more information

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Naltrexone

Other:
Intravail


Locations

Country Name City State
United States Vince and Associates Clinical Research, Inc. Overland Park Kansas

Sponsors (1)

Lead Sponsor Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plasma Concentration (Cmax) Measurement of serum naltrexone prior to dosing and at times 2, 3, 4, 6, 8, 12, 16, 24, 30, 36 and 48 hours after naltrexone administration 48 hours No
Primary Plasma Concentration (Tmax) Measurement of serum naltrexone prior to dosing and at times 2, 3, 4, 6, 8, 12, 16, 24, 30, 36 and 48 hours after naltrexone administration 48 hours No
Primary Plasma Concentration (AUC 0-t) Measurement of serum naltrexone prior to dosing and at times 2, 3, 4, 6, 8, 12, 16, 24, 30, 36 and 48 hours after naltrexone administration 48 hours No
Primary Plasma Concentration (AUC 0-inf) Measurement of serum naltrexone prior to dosing and at times 2, 3, 4, 6, 8, 12, 16, 24, 30, 36 and 48 hours after naltrexone administration 48 hours No
Secondary Adverse Events Will be reported from the start of the first session to follow-up visit Maximum of 18 days Yes
Secondary Vital Signs Measured before and after naltrexone administration 12 days Yes
Secondary 12-lead electrocardiogram Measured before and after naltrexone administration 12 days Yes
Secondary Nasal Irritation Scoring Will be reported from the start of the first session to follow-up visit 5 days Yes
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