A study in healthy volunteers to look at safety and tolerability of ALKS 4510
| ISRCTN | ISRCTN70607799 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70607799 |
| Secondary identifying numbers | ALKS 4510-101 |
- Submission date
- 06/05/2025
- Registration date
- 20/05/2025
- Last edited
- 19/05/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
This clinical study assesses how safe and well-tolerated an investigational drug is in a healthy adult population.
Who can participate?
Healthy adults aged 18-55 years
What does the study involve?
Part 1 is designed to assess the effect of a single dose of ALKS 4510 in healthy participants. Participants will have three study visits, which include a screening, a treatment period with four consecutive overnight stays, and a safety follow-up.
Part 2 is designed to assess the effect of multiple daily doses of ALKS 4510 in healthy participants. Participants will have 3 study visits, which include a screening, a treatment period with 12 consecutive overnight stays and a safety follow-up.
What are the possible benefits and risks of participating?
This is a phase 1 healthy volunteer study, and participants will be administered the study drug for research purposes only. This trial may help reveal important scientific knowledge that could contribute to the development of a drug.
As with all interventional studies, the drug treatment may involve side effects. Participants will be carefully monitored for any side effects; however, not all of the side effects that the study drug may have are known.
Where is the study run from?
Alkermes, Inc. (USA). The study is conducted at a phase 1 clinical trial site in Australia
When is the study starting and how long is it expected to run for?
May 2025 to November 2025
Who is funding the study?
Alkermes, Inc. (USA)
Who is the main contact?
Clinicaltrials@alkermes.com
Contact information
Public, Scientific
Alkermes
900 Winter Street
Waltham
02451
United States of America
| Phone | +1 571-599-2702 |
|---|---|
| clinicaltrials@alkermes.com |
Principal Investigator
Bright Building, Level 5
Corner High and Avoca Street
Randwick
NSW 2031
Australia
| Phone | +1 571-599-2702 |
|---|---|
| clinicaltrials@alkermes.com |
Study information
| Study design | Single-centre randomized double-blind placebo-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Safety |
| Participant information sheet | No participant information sheet available |
| Scientific title | A randomized, double-blind, placebo-controlled, first-in-human study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ALKS 4510 in healthy subjects |
| Study objectives | Study to assess the safety, tolerability and pharmacokinetics of single-ascending and multiple-ascending doses of ALKS 4510 |
| Ethics approval(s) |
Submitted 19/03/2025, Bellberry Human Research Ethics Committee (HREC) (123 Glen Osmond Road, Eastwood, 5063, Australia; +61 9 8361 3222; bbl@bellberry.com.au), ref: 2025-02-229 |
| Health condition(s) or problem(s) studied | Phase 1 study drug |
| Intervention | Part 1 SAD: Healthy volunteers will be randomized by using a randomization code to receive a single dose of oral ALKS 4510 or placebo for 1 day in each of five cohorts Part 2 MAD: Healthy volunteers will be randomized by using a randomization code to receive one dose of oral ALKS 4510 or placebo every day for 10 consecutive days in each of four cohorts |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Pharmacokinetic, Dose response |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | ALKS 4510 |
| Primary outcome measure | Incidence of Treatment-Emergent Adverse Events by monitoring case report forms through dosing and safety follow up to 17 days |
| Secondary outcome measures | Levels of ALKS 4510 in blood measured as Cmax , Tmax (Day 1), AUC (over 12 hours), T-half, CL /F, and Vz/F using pharmacokinetic non-compartmental methods at 3 study visits with duration of participation of about 17 days |
| Overall study start date | 31/05/2024 |
| Completion date | 30/11/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 55 Years |
| Sex | Both |
| Target number of participants | 72 |
| Key inclusion criteria | 1. Participants must be 18 to 55 years of age, inclusive, at the time of informed consent 2. Willing and able to provide informed consent before study participation 3. Has a BMI ≥18 and ≤30 kg/m2 4. Is overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, vital signs, and safety ECGs 5. Must adhere to contraceptive use |
| Key exclusion criteria | 1. Subjects who have demonstrated allergic reactions (eg, food, drug, atopic reactions, or asthmatic episodes) which, in the opinion of the Investigator, interfere with their ability to participate in the study 2. The subject has poor peripheral venous access 3. Clinically significant illness or disease (eg, psychiatric disorders, disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system (including any sleep disorder such as sleep apnea or narcolepsy), or cardiovascular system, infection, visual conditions, or subjects who have a congenital abnormality in metabolism) 4. Any history at Screening of gastrointestinal or renal surgery that may affect PK profiles of ALKS 4510 (eg, hepatectomy, nephrectomy, digestive organ resection, or surgery that alters the gastrointestinal tract without resection), or other conditions that may impact absorption (malabsorption syndrome, inflammatory bowel disease, etc). Uncomplicated appendectomy and/or hernia repair are allowed 5. Is currently pregnant or breastfeeding, or is planning to become pregnant during the study |
| Date of first enrolment | 12/05/2025 |
| Date of final enrolment | 30/11/2025 |
Locations
Countries of recruitment
- Australia
Study participating centre
Corner High and Avoca Street
Randwick
2031
Australia
Sponsor information
Industry
900 Winter Street
Waltham
02451
United States of America
| Phone | +1 571-599-2702 |
|---|---|
| clinicaltrials@alkermes.com | |
| Website | https://www.alkermes.com/ |
"ROR" |
https://ror.org/038hqfn26 |
Funders
Funder type
Industry
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Alkermes plc
- Location
- Ireland
Results and Publications
| Intention to publish date | 01/11/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available as they are intellectual property |
Editorial Notes
07/05/2025: Study's existence confirmed by the Bellberry Human Research Ethics Committee (HREC).
