CompletedPhase 1

Safety, Tolerability, and Pharmacokinetics of Naltrexone Implant (DLP-160)

Australia10 participantsStarted 2022-03-22

Plain-language summary

This is an Open-Label Study in Healthy Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics of Switching from Oral Naltrexone HCL to DLP-160 (Naltrexone implant) to Intramuscular Vivitrol®

Who can participate

Age range18 Years – 50 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

✓. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
✓. Adult males and females, 18 to 50 years of age (inclusive) at the time of screening.
✓. Body Mass Index (BMI) greater than or equal to 18.0 and lesser than or equal to 30.0 kg/m2, with a body weight (to 1 decimal place) greater than or equal to 50 kg.
✓. Medically healthy without clinically significant abnormalities (in the opinion of the Investigator) at the screening visit and prior to administration of the first study dose on study Day -6, including:
✓. Physical examination without any clinically significant findings.
✓. Systolic blood pressure in the range of 90 to 160 mmHg (inclusive) and diastolic blood pressure in the range of 50 to 95 mmHg (inclusive) after 5 minutes in supine (or semi-supine) position.
✓. Heart rate (HR) in the range of 45 to 100 bpm (inclusive) after 5 minutes rest in a supine (or semi-supine) position.
✓. Body temperature (tympanic or oral) in the range 35.5°C to 37.7°C (inclusive).

Exclusion criteria

✕. History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or major surgery within the past 3 months determined by the PI to be clinically significant (participants with resolved childhood asthma may be included in the study).
✕. Current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications.
✕. Liver function test results elevated more than 1.5-fold above the upper limit of normal (ULN) for gamma glutamyl transferase (GGT), bilirubin (total, conjugated and unconjugated), alkaline phosphatase (ALP), aspartate aminotransferase (AST) or alanine aminotransferase (ALT). Volunteers with ALP and/or ALT/AST above the limits specified may be included, at the discretion of the Investigator, if the levels are unaccompanied by clinical signs and are determined to be normal variants.
✕. Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at the screening visit.
✕. Presence or having sequelae of gastrointestinal, liver, kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs (prior gall bladder and/or appendix removal is not exclusionary if deemed appropriate by the Investigator).
✕. Estimated creatinine clearance (CrCl) less than 80 mL/min using the Cockcroft-Gault formula or serum creatinine more than 1.5-fold above the ULN.
✕. Presence of clinically significant skin disorders (such as, but not limited to, skin cancer, psoriasis, eczema, or atopic dermatitis), evidence of recent sunburn, scar tissue, tattoo, open sore, body piercing or branding at the intended placement site that would interfere with the placement procedure or interfere with implant site assessments as determined by the Investigator.
✕

What they're measuring

DLP-160 Adverse Events

Timeframe: Day 1 to Day 120

DLP-160 Local Tolerance

Timeframe: Day 1 to Day 120

Tolerability of DLP-160 Implantation and Removal Procedures

Timeframe: Day 1 to Day 120

Trial details

NCT IDNCT05304364

SponsorDelpor, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-10-21

View on ClinicalTrials.gov More Opiod Use Disorder trials

Who can participate

Age range18 Years – 50 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

✓. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
✓. Adult males and females, 18 to 50 years of age (inclusive) at the time of screening.
✓. Body Mass Index (BMI) greater than or equal to 18.0 and lesser than or equal to 30.0 kg/m2, with a body weight (to 1 decimal place) greater than or equal to 50 kg.
✓. Medically healthy without clinically significant abnormalities (in the opinion of the Investigator) at the screening visit and prior to administration of the first study dose on study Day -6, including:
✓. Physical examination without any clinically significant findings.
✓. Systolic blood pressure in the range of 90 to 160 mmHg (inclusive) and diastolic blood pressure in the range of 50 to 95 mmHg (inclusive) after 5 minutes in supine (or semi-supine) position.
✓. Heart rate (HR) in the range of 45 to 100 bpm (inclusive) after 5 minutes rest in a supine (or semi-supine) position.
✓. Body temperature (tympanic or oral) in the range 35.5°C to 37.7°C (inclusive).

Exclusion criteria

✕. History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or major surgery within the past 3 months determined by the PI to be clinically significant (participants with resolved childhood asthma may be included in the study).
✕. Current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications.
✕. Liver function test results elevated more than 1.5-fold above the upper limit of normal (ULN) for gamma glutamyl transferase (GGT), bilirubin (total, conjugated and unconjugated), alkaline phosphatase (ALP), aspartate aminotransferase (AST) or alanine aminotransferase (ALT). Volunteers with ALP and/or ALT/AST above the limits specified may be included, at the discretion of the Investigator, if the levels are unaccompanied by clinical signs and are determined to be normal variants.
✕. Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at the screening visit.
✕. Presence or having sequelae of gastrointestinal, liver, kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs (prior gall bladder and/or appendix removal is not exclusionary if deemed appropriate by the Investigator).
✕. Estimated creatinine clearance (CrCl) less than 80 mL/min using the Cockcroft-Gault formula or serum creatinine more than 1.5-fold above the ULN.
✕. Presence of clinically significant skin disorders (such as, but not limited to, skin cancer, psoriasis, eczema, or atopic dermatitis), evidence of recent sunburn, scar tissue, tattoo, open sore, body piercing or branding at the intended placement site that would interfere with the placement procedure or interfere with implant site assessments as determined by the Investigator.
✕