Multiple ascending dose study of ALKS 7119
- Conditions
- Proof of pharmacology
- Registration Number
- NL-OMON27126
- Lead Sponsor
- Alkermes, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 48
1. Willing and able to provide informed consent
2. Capable of understanding and complying with the protocol
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety: Evaluation of safety will be based on the occurrence of adverse events (AEs), vital signs, results of clinical laboratory tests electrocardiogram (ECG) parameters, real-time ECG parameters. Reported AE terms will be coded using the Medical Dictionary for Regulatory Activities (MedDRA® version 19.0 or higher) preferred terms and system organ classes.<br>
- Secondary Outcome Measures
Name Time Method