The Evaluation of Safety and Tolerance of Commercially Available Naltrexone Administered Daily - Assessment for CBRN Operations

NCT03879460 | Completed Phase 1

• 1 other identifier: 2018-044
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the tolerance and safety of naltrexone while performing military specific tasks, and to assess plasma concentrations following naltrexone, administered orally at 50 mg per day for 7 days. The physical and mental/cognitive performance assessments will be conducted at various times prior, during and following drug administration. Daily blood draws will also be taken to assess blood levels of naltrexone and active metabolites for correlation to performance parameters associated with the Military Skill \& Tasked Based Fitness Test.

Conditions

Opioid Intoxication

Outcome Measures

Primary Outcomes (1)

• Plasma concentration of naltrexone and its active metabolite, 6 beta naltrexol

  Study day 4 - 10

Study Arms (1)

Open Label

EXPERIMENTAL

Open label

Drug: Naltrexone Hydrochloride

Interventions

Naltrexone Hydrochloride DRUG

50 mg per os naltrexone hydrochloride

Open Label

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Non pregnant
• between 18 and 55 years;
• Body weight with a BMI range of 18.5 to 27.0 \[or weight within 15% of ideal weight for subject's height and frame (to be based on Metropolitan Life Insurance Company weight tables);
• Healthy, with normal findings in the physical examination and vital signs (BP between 100-140/60-90 mmHg, HR between 60 to 90 beats/min, respiration between 12 to 24 breaths/min, SpO2 \>90% breathing room air) and no clinically-significant findings in a 12-lead electrocardiogram;
• No clinical laboratory values outside of the laboratory normal reference range, unless the investigator determines them to be not clinically significant;
• Non-smoking (i.e. having no history of tobacco, or other substance, smoking for greater than or equal to 12 months, and not having smoked within the past year by self-report);
• Negative tests for smoking tobacco (urine cotinine test), alcohol (urine test), hepatitis B- surface antigen, hepatitis C antibody, tuberculin skin-prick test at screening;
• Negative urine screen for drugs of abuse;
• Willing and able to communicate well with the investigator and clinic staff, comply with the study procedure and schedule, and provide written informed consent;
• Able to understand the requirements of the study and sign informed consent;

You may not qualify if:

• Current major Axis I psychiatric disorder for which the subject is currently receiving treatment or which would make study compliance an issue;
• Pregnant. A test will be available for prospective participants;
• Breast-feeding women;
• Any condition or therapy which, in the opinion of the investigator, may be significantly worsened by the administration of naltrexone or is likely to interfere with the successful collection of the measures required;
• Acute disease at the time of enrolment (i.e. presence of a moderate or severe illness or infection with or without a fever);
• Febrile illness (oral temperature \>37.6º C at the time of drug administration);
• Unstable chronic illnesses;
• Chronic liver, renal or inflammatory bowel disease or collagen vascular disease;
• Clinically significant elevation of ALT and/or AST;
• Active neurological disorder;
• Clinically significant uncontrolled illness or clinically significant surgery within 4 weeks prior to administration of study drug;
• Cancer within the previous 5 years, other than squamous cell or basal cell carcinoma of the skin;
• History of any clinical laboratory abnormality deemed significant by the Principal Investigator;
• History of serious adverse reaction or hypersensitivity to any drug;
• Bleeding tendency resulting from disease or medication rendering blood collection or the injection itself unsafe (use of antiplatelet agents is allowed);

Sponsors & Collaborators

• Timothy Smith: lead

Study Sites (1)

Department of National Defence

Ottawa, Ontario, K1A 0K2, Canada

Location

MeSH Terms

Interventions

Naltrexone

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Regulatory & Product Development Specialist

Model Details: Open label safety assessment

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 18, 2019
• Study Start: March 18, 2019
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: May 17, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)