Phase 1 study drug Other
Conditions
Interventions
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
Sponsors
Alkermes (United States)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Treatment-Emergent Adverse Events by monitoring case report forms through dosing and safety follow up to 17 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Australia
Contacts
Public ContactClinical Operations
Outcome results
None listed