Opiod Use DisorderPhase 1NCT05304364
Safety, Tolerability, and Pharmacokinetics of Naltrexone Implant (DLP-160)
A Phase 1 study testing Combination Product: Naltrexone in people with Opiod Use Disorder, run by Delpor, Inc. at 1 site in Australia.
Trial 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® Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Opiod Use Disorder
- What is being tested?
- Combination Product: Naltrexone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteAustralia
- Study dates
- 22 Mar 2022to 19 Nov 2022
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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).
- No clinically significant findings in serum chemistry, haematology, coagulation, and urinalysis tests.
- Triplicate 12-lead ECG (taken after the volunteer has been supine (or semi-supine) for at least 5 minutes) with a QT interval corrected using the Fridericia method (QTcF) lesser than or equal to 450 msec for males and lesser than or equal to 470 msec for females and no clinically significant abnormalities.
- Note: Minor abnormalities or deviations outside the normal ranges for any of the clinical testing (laboratory tests, ECG, vital signs) may be repeated at the discretion of the Investigator. Such abnormalities or deviations are acceptable for participation in the study if judged to be not clinically significant by the Investigator. Platelet count and coagulation measures must be within normal limits.
- Female volunteers must:
- Be of nonchildbearing potential i.e., be surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before screening) or be postmenopausal, where menopause is defined as 12 months of amenorrhea in the absence of other biological causes (females under the age of 55 years must have a documented serum follicle stimulating hormone (FSH) level greater than 40mIU/mL to confirm menopause).
- If of childbearing potential (defined as any female who has experienced menarche and who has not undergone surgical sterilisation and is not postmenopausal), the participant:
- Must have a negative serum test at the screening visit and a negative urine pregnancy test within 24 hours prior to the start of study drug.
- Must not be breastfeeding, lactating or planning pregnancy during the study period.
- Must agree not to attempt to become pregnant.
- If not exclusively in same-sex relationships, must agree to use adequate contraception (which is defined as use of a condom by the male partner combined with use of a highly effective method of contraception by the female partner); after signing consent, during the study, and at least 35 days after the last dose of study drug;
- Must agree to not donate ova for at least 35 days after the last dose of study drug.
- Male participants, if not surgically sterilised, must agree to:
- Not donate sperm after signing consent, during the study, and at least 95 days after the last dose of study drug.
- If engaging in sexual intercourse with a female partner who could become pregnant, use a condom in addition to having the female partner use a highly effective contraceptive method.
- Have suitable venous access for blood sampling.
- Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
Who cannot join
- 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.
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- 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.
- History of abnormal scar formation or family history of keloid formation.
- Known hypersensitivity to titanium, implant materials or the procedure of implant placement.
- Previously defined hypersensitivity to Naltrexone.
- Known hypersensitivity or allergy to lidocaine or any local anaesthetic agent of the amide type (local anaesthetic used during placement and removal procedures).
- History of substance abuse, in the opinion of the Investigator.
- History of alcohol abuse (defined as more than an average of 14 standard drinks per week or regular consumption of more than 4 standard drinks on any one day; where 1 standard drink is 10 g of pure alcohol and is equivalent to 285 mL beer [4.9% Alc./Vol], 100 mL wine [12% Alc./Vol], 30 mL spirit [40% Alc./Vol]).
- Positive drugs of abuse or alcohol breath test results at the screening visit or prior to the first study drug administration on Day -6 and at check-in on Day -2.
- Use of any prescription or over-the-counter medication (including herbal products, and hormone supplements) within 10 days or 5 half-lives of the medication (whichever is longer) prior to the first study drug administration - exceptions include contraceptives for females, occasional use of paracetamol (doses of 500 mg up to every 6 hours or 2 g per day maximum for no more than 3 consecutive days), ibuprofen (doses of 400 mg up to every 6 hours or 1.2 g per day maximum for no more than 3 consecutive days), topical ointments, and vitamins or dietary supplements.
- Demonstrated clinically significant (required intervention, e.g., emergency room visit, epinephrine administration) allergic reactions (e.g., food, drug, or atopic reactions, asthmatic episodes) which, in the opinion of the Investigator, would interfere with the volunteer's ability to participate in the trial.
- For women of childbearing potential, a positive serum pregnancy test at the screening visit or a positive urine pregnancy test (with confirmatory serum pregnancy test) prior to the first study drug administration on Day -6 and at check-in on Day -2.
- Females who are breastfeeding or planning to breast feed at any time during the study.
- Donation of blood or plasma within 30 days prior to first study drug administration, or loss of whole blood of more than 500 mL within 30 days prior to first study drug administration, or receipt of a blood transfusion within 1 year of first study drug administration.
- Intolerance of direct venepuncture.
- Treatment with an investigational drug (or device) in another clinical trial within 30 days or 5 half-lives of the other investigational drug (whichever is longer) prior to the first administration of study drug in this trial.
- Anticipated surgical procedure or current painful condition that is likely to require opioid analgesia during the trial.
- Any other condition or prior therapy that in the opinion of the Investigator would make the volunteer unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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®
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®
Read the detailed description
This study is first-in-man clinical study of DLP-160, a Naltrexone implant product. The study is an open-label, single sequence design aimed at assessing the safety and tolerability of DLP-160 and evaluating its utility in achieving a PK profile that is comparable to the marketed oral and injectable forms of Naltrexone.
Initially, a group of 2 healthy volunteers will receive the Naltrexone HCL followed by DLP-160 implant as a sentinel group. The safety and tolerability of the DLP-160 implant will be assessed in the sentinel group for at least 28 days prior to any other volunteers being implanted with DLP-160 in the study. Only if the safety and tolerability data, obtained from the sentinel group, are considered acceptable by the Investigator, will the remainder of healthy volunteers commence treatment in the study.
Healthy volunteers will be enrolled and implanted with DLP-160 involving treatment of each study participant consisting of 3 sequential treatment periods with a washout period between treatments.
- Naltrexone HCL treatment (oral; 50 mg/day) (Day -6 to Day -2);
- Washout (Day -1);
- DLP-160 implant treatment (up to 123 days);
- DLP-160 removal and washout (1 day);
- Vivitrol® treatment (single intramuscular injection with a 30 day follow up);
- Follow up to completion of study participation (7 days).
- Conditions
- Opiod Use Disorder
- Being tested
- Combination Product: Naltrexone
- Keywords
- Naltrexone, Addiction, Mental Health, Implant
- Medical subject headings
- Behavior, Addictive, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination Product: NaltrexoneCombination product
Also called DLP-160
Naltrexone Implant
| Study group | Role | What they receive |
|---|---|---|
| DLP-160 alpha-10 | Experimental | One time single Naltrexone Implant for a duration of 123 days Receives: Combination Product: Combination Product: Naltrexone |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLP-160 Adverse Events
Determine the number and percent of patients experiencing a treatment-emergent adverse event
Measured: Day 1 to Day 120
DLP-160 Local Tolerance
Evaluate the incidence of local site reactions
Measured: Day 1 to Day 120
Tolerability of DLP-160 Implantation and Removal Procedures
Assess the incidence of local site reactions and/or Adverse Events (AEs) reported during the implantation and removal procedure
Measured: Day 1 to Day 120
Secondary outcomes (4)
Oral Pharmacokinetic (PK) Profile
Measure the plasma concentration of Naltrexone, 6-β-naltrexol and active moiety (Naltrexone + 6-β-naltrexol) following:
- Repeated oral administrations Naltrexone HCL
Measured: 24 hours
Implant Pharmacokinetic (PK) Profile
Measure the plasma concentration of Naltrexone, 6-β-naltrexol and active moiety (Naltrexone + 6-β-naltrexol) following:
- Following treatment switch from oral Naltrexone HCL to subcutaneous placement of one DLP-160 implant
Measured: 4 months
IM Naltrexone PK Profile
Measure the plasma concentration of Naltrexone, 6-β-naltrexol and active moiety (Naltrexone + 6-β-naltrexol) following:
- Following treatment switch from one DLP-160 implant to a single IM dose of Vivitrol®.
Measured: 1 month
Evaluate the Drug Output of the DLP-160 Implant
Evaluate the amount of Naltrexone drug substance remaining in the DLP-160 implant drug reservoir following its removal and estimating daily drug output of the DLP-160 implant.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start22 Mar 2022
- Primary completion21 Oct 2022
- Study completion19 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opiod Use DisorderStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delpor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alex Choo, MD, Principal investigator, CMAX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05304364
- Sponsor's protocol ID
- DLP-160-01
- Status last verified
- Feb 2025
- First submitted
- 7 Mar 2022
- Last updated
- 13 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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®
- ClinicalTrials.gov ID
- NCT05304364
- Acronym / sponsor ID
- DLP-160-01
- Conditions
- Opiod Use Disorder
- Keywords
- Naltrexone, Addiction, Mental Health, Implant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Delpor, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 21 Oct 2022 (actual)
- Study completion
- 19 Nov 2022 (actual)
- First posted
- 31 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.
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®
Detailed description
This study is first-in-man clinical study of DLP-160, a Naltrexone implant product. The study is an open-label, single sequence design aimed at assessing the safety and tolerability of DLP-160 and evaluating its utility in achieving a PK profile that is comparable to the marketed oral and injectable forms of Naltrexone.
Initially, a group of 2 healthy volunteers will receive the Naltrexone HCL followed by DLP-160 implant as a sentinel group. The safety and tolerability of the DLP-160 implant will be assessed in the sentinel group for at least 28 days prior to any other volunteers being implanted with DLP-160 in the study. Only if the safety and tolerability data, obtained from the sentinel group, are considered acceptable by the Investigator, will the remainder of healthy volunteers commence treatment in the study.
Healthy volunteers will be enrolled and implanted with DLP-160 involving treatment of each study participant consisting of 3 sequential treatment periods with a washout period between treatments.
- Naltrexone HCL treatment (oral; 50 mg/day) (Day -6 to Day -2);
- Washout (Day -1);
- DLP-160 implant treatment (up to 123 days);
- DLP-160 removal and washout (1 day);
- Vivitrol® treatment (single intramuscular injection with a 30 day follow up);
- Follow up to completion of study participation (7 days).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DLP-160 alpha-10 | Experimental | Combination Product: Combination Product: NaltrexoneOne time single Naltrexone Implant for a duration of 123 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (24 listed)
- 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:
- Note: Minor abnormalities or deviations outside the normal ranges for any of the clinical testing (laboratory tests, ECG, vital signs) may be repeated at the discretion of the Investigator. Such abnormalities or deviations are acceptable for participation in the study if judged to be not clinically significant by the Investigator. Platelet count and coagulation measures must be within normal limits.
Key exclusion criteria (23 listed)
- 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).
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 |
|---|---|---|
| Combination Product: NaltrexoneAlso: DLP-160Naltrexone Implant | Combination product | DLP-160 alpha-10 |
Primary outcome
DLP-160 Adverse Events
Time frame: Day 1 to Day 120
Determine the number and percent of patients experiencing a treatment-emergent adverse event
DLP-160 Local Tolerance
Time frame: Day 1 to Day 120
Evaluate the incidence of local site reactions
Tolerability of DLP-160 Implantation and Removal Procedures
Time frame: Day 1 to Day 120
Assess the incidence of local site reactions and/or Adverse Events (AEs) reported during the implantation and removal procedure
4 secondary outcomes
Oral Pharmacokinetic (PK) Profile
Time frame: 24 hours
Implant Pharmacokinetic (PK) Profile
Time frame: 4 months
IM Naltrexone PK Profile
Time frame: 1 month
Evaluate the Drug Output of the DLP-160 Implant
Time frame: 4 months
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 13 Feb 2025.
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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.
Alex Choo, MD principal investigator
CMAX
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 Combination Product: Naltrexone in people with Opiod Use Disorder, run by Delpor, Inc. at 1 site in Australia.
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 24 inclusion and 23 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 13 Feb 2025. 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 Australia. 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?
DLP-160 Adverse Events (time frame: Day 1 to Day 120). The study lists 3 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 13 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.