A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of ALKS 7119 in Healthy Adults

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 48

Inclusion Criteria

1. Is willing and able to provide informed consent
2. Is capable of understanding and complying with the protocol
3. Is male or female adult and *18 and *45 years of age, inclusive, at
screening (Visit 1)
4. Has a body mass index *18.0 and *32.0 kg/m2 at screening
5. Agrees to use an acceptable method of contraception from 30 days
prior to screening and for 90 days after any study drug administration,
or must be surgically sterile or post-menopausal (if female)

Exclusion Criteria

1. Clinically significant medical condition or observed abnormalities, in the opinion of the investigator (including, clinically significant physical examination finding, vital sign result, ECG result, laboratory or urinalysis test result) and/or any other finding that, in the investigator*s judgment, could potentially compromise subject safety, or PK or PD evaluation, or affect the subject*s ability to adhere to the protocol visit schedule, or fulfill visit requirements
2. Female subject that is currently pregnant or breastfeeding, or plans to become pregnant or begin breastfeeding at any point during the study and for 90 days after any study drug administration
3. Has a history of intolerance or hypersensitivity to dextromethorphan or any dextromethorphan-containing product
4. Has had a clinically significant illness in the 30 days prior to first study drug administration (Day 1)
5. Has a positive drug screen for at screening (Visit 1) or upon admission (Day -1)
6. Has a positive breath test for alcohol at screening (Visit 1) or upon admission (Day -1)
7. Has a positive serology test for hepatitis B virus surface antigen (HBsAg), hepatitis B virus core antibody (HBcAb), hepatitis C virus antibody (HCVAb), or human immunodeficiency virus antibody (HIVAb) at screening (Visit 1)
8. Has a clinically significant lifetime history of suicidal ideation or suicidal behavior and/or poses a current (within past year) suicide risk
9. Has used any prescription or over-the-counter medication, including herbal remedies and nutritional supplements (except vitamins), within 7 days prior to screening (Visit 1) or admission (Day -1)
10. Has ingested any alcohol, caffeine or xanthine within 24 hours prior to inpatient admission (Day -1), or excessive caffeine consumption (defined as *800 mg per day) at screening (Visit 1)
11. Has used any product containing nicotine within 30 days prior to admission (Day -1)
12. Has participated in a clinical trial of an investigational product within 3 months prior to screening (Visit 1) or participated in more than four investigational drug studies within 1 year prior to screening (Visit 1)
13. Has previously participated in a clinical trial with ALKS 7119

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety and tolerability: Evaluation of safety will be based on the occurrence<br /><br>of adverse events (AEs), vital signs, results of clinical laboratory tests<br /><br>electrocardiogram (ECG) parameters, real-time ECG parameters. Reported AE terms<br /><br>will be coded using the Medical Dictionary for Regulatory Activities (MedDRA®<br /><br>version 19.0 or higher) preferred terms and system organ classes.</p><br>

Secondary Outcome Measures