A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ALKS 6610 with a Pilot Evaluation of Food Effect in Healthy Adult Subjects

Completed

• Conditions: Pain; Chronic pain

• Registration Number: NL-OMON50062
• Lead Sponsor: Alkermes, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2021-10-12
• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 56

Inclusion Criteria

1. Signed informed consent prior to any study-mandated procedure
2. Ability to communicate well with the Investigator in the Dutch language and
willing to follow the procedures and comply with study restrictions as outlined
in the protocol
3. Male or female age *18 years and *60 years old at the time of informed
consent
4. Body mass index (BMI) *18 and <30 kg/m2 at Screening

Exclusion Criteria

1. Clinically significant illness or disease (e.g. psychiatric disorders,
disorders of the gastrointestinal tract, liver [including Gilbert*s syndrome],
kidney [including nephrectomy], respiratory system, endocrine system,
haematological system, neurological system, or cardiovascular system,
infection, or subjects who have a congenital abnormality in metabolism) within
8 weeks of dosing, or any clinically abnormal symptom or organ impairment, as
judged by the Investigator, found by medical history, physical examinations,
vital signs, electrocardiogram (ECG) finding, or either abnormal laboratory
values or laboratory test results at Screening or Baseline (either Day -2 or
Day -1)
2. Presence of any condition in which an opioid is contraindicated (e.g.
respiratory depression, asthma, sleep apnea, ileus, etc.), unless regarded not
clinically significant by the Investigator
3. Females who are breastfeeding or pregnant at Screening or Baseline (Day -2)
(documented by a negative * human chorionic gonadotropin [*-hCG] or human
chorionic gonadotropin [hCG] test with a minimum sensitivity of 25 IU/L or
equivalent units of *-hCG [or hCG]). A negative urine pregnancy test is
required before the administration of the first dose per cohort
4. Females of childbearing potential. NOTE: All females will be considered to
be of childbearing potential unless they are postmenopausal (amenorrheic for at
least 12 consecutive months, and without other known or suspected cause) or
have been sterilized surgically (i.e. bilateral tubal ligation, total
hysterectomy, or bilateral oophorectomy, all with surgery at least 6 weeks
before dosing)
5. Any history of gastrointestinal surgery that may affect PK profiles of ALKS
6610 (e.g. hepatectomy, digestive organ resection) or other conditions that may
impact absorption (malabsorption syndrome, inflammatory bowel disease, etc.) at
Screening
6. A prolonged QT/QTc interval (QTcF >450 ms in males, and QTcF >470 ms in
females) demonstrated on ECG at Screening or Baseline (either Day -2 or Day
-1). A history of risk factors for torsade de pointes (e.g. heart failure,
hypokalaemia, family history of long QT Syndrome)
7. Left bundle branch block at Screening or Baseline (either Day -2 or Day -1)
8. Systolic blood pressure (BP) >140 or <90 mmHg or diastolic BP >90 or <50
mmHg at Screening or Baseline (either Day -2 or Day -1) or history of
clinically relevant orthostatic hypotension
9. Heart rate less than 45 beats per minute (bpm) or more than 100 bpm at
Screening or Baseline (either Day -2 or Day -1)
10. History of myocardial infarction, ischemic heart disease, or cardiac
failure at Screening
11. History of clinically significant arrhythmia or uncontrolled arrhythmia as
determined by the Investigator at screening
12. Subjects who have demonstrated allergic reactions (e.g. food, drug, atopic
reactions or asthmatic episodes) which, in the opinion of the Investigator,
interfere with their ability to participate in the trial
13. Positive Hepatitis A antibodies (HAV IgM), Hepatitis B surface antigen
(HBsAg), Hepatitis B antibodies (Anti-HBc), Hepatitis C antibodies (HCV Ab), or
human immunodeficiency virus antibody (HIV Ab) at Screening
14. Use of nicotine containing products within 2 weeks before the first dose of
study drug (Day 1)
15. His

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Tolerability / Safety Endpoints<br /><br>Pharmacokinetic Endpoints</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Pharmacodynamic Endpoints</p><br>