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

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

1. Is willing and able to give informed consent
2. Is capable of understanding and complying with the protocol
3. Is male, and *18 and *45 years of age at screening
4. Has a body-mass index *18.0 and *32.0 kg/m2 at screening
5. Agrees to use an acceptable method of contraception for the duration of the study as outlined in Section 9.4.1 of the protocol and for 90 days after any study drug administration

Exclusion Criteria

1. Has a clinically significant medical condition or observed abnormalities in the opinion of the Investigator (including physical examination results, vital sign results, ECG results, laboratory blood sample test results [particularly kidney function, liver function, and hematology test results], and urinalysis)
2. Has a corrected QT interval (Fridericia correction; QTcF) t;450 milliseconds, PR interval t;220 milliseconds, or any other ECG finding that, in the opinion of the investigator, might compromise subject safety
3. Has a thyroid stimulating hormone (TSH) level greater than 10% above or below the normal range at screening
4. Has a history of intolerance or hypersensitivity to dextromethorphan or any dextromethorphan-containing product
5. Has had a clinically significant illness in the 30 days prior to first study drug administration (Day 1)
6. Has a positive drug screen for alcohol, amphetamines, methamphetamine, barbiturates, benzodiazepines, cocaine, tetrahydrocannabinol (THC), methadone, or opiates at screening or upon inpatient admission
7. Has a positive serology test for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCVAb), or human immunodeficiency virus antibody (HIVAb) at screening
8. Has a lifetime history of diabetes or Hemoglobin A1c (glycosylated hemoglobin) >6% at screening
9. Has used any prescription or over-the-counter medication, including herbal remedies and nutritional supplements (except vitamins), within 7 days prior to screening or inpatient admission
10. Has ingested any alcohol, caffeine, or xanthine within 24 hours prior to inpatient admission, or excessive caffeine consumption (defined as *800mg per day) at screening
11. Has used any product containing nicotine within 30 days prior to the inpatient admission
12. Has participated in a clinical trial of an investigational product within 3 months or participated in more than four investigational drug studies within 1 year prior to screening
13. Has lost >500 mL of blood or donated blood within 90 days prior to inpatient admission or donated blood product of any type (eg, plasma) within 14 days prior to inpatient admission
14. Has a history of treatment non-adherence or poor clinic visit attendance or the principal investigator (PI) or designee has reason to believe that the subject may be unable to fulfill the protocol visit schedule or requirements
15. Requires a special diet, has a significant food allergy or intolerance, or is not willing to abide by the diet provided by the site
16. Is employed by Alkermes, the investigator or study site, (permanent, temporary contract worker, or designee responsible for the conduct of the study) or is immediate family* of an Alkermes, investigator, or study site employee
* Immediate family is defined as a spouse, parent, sibling, or child, whether biological or legally adopted