No registrations found.
ID
Source
Brief title
Health condition
Single Ascending Dose Study
Sponsors and support
Intervention
Outcome measures
Primary outcome
Tolerability / Safety Endpoints
Pharmacokinetic Endpoints
Secondary outcome
NA
Background summary
Subjects will be recruited in The Netherlands to participate in a Single Ascending Dose Study of ALKS 6610 in healthy adults. The study results may be used to support further clinical development of ALKS 6610.
Study objective
The objective of the study is to evaluate safety, tolerability, and pharmacokinetics (PK) of ALKS 6610 after single ascending oral doses in healthy adult subjects.
Study design
Baseline till EOS
Intervention
ALKS 6610 or placebo
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 within 8 weeks of dosing, or any clinically abnormal symptom or organ impairment, found by medical history, physical examinations, vital signs, electrocardiogram (ECG) finding, or either abnormal laboratory values or laboratory test results at Screening or Baseline
2. Females who are breastfeeding or pregnant at Screening or Baseline
3. Females of childbearing potential. NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal or have been sterilized surgically
4. A prolonged QT/QTc interval (QTcF >450 ms in males, and QTcF >470 ms in females) demonstrated on ECG at Screening or Baseline
5. History of clinically significant arrhythmia or uncontrolled arrhythmia
6. 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
7. Use of nicotine containing products within 2 weeks before the first dose of study drug (Day 1)
8. Use of prescription and non-prescription medications, herbal and nutritional supplements within 2 weeks prior to dosing or 5 half-lives, whichever is longer.
9. Any history of lifetime suicidal ideation or behaviour, confirmed by a Columbia Suicide Severity Rating Scale (C-SSRS) response of “Yes” to questions 4 or 5 at Screening
10. Currently enrolled in another clinical study, used any investigational drug or device within 3 months prior to dosing, or having participated in more than 4 investigational drug studies within 1 year prior to Screening
11. Additional criteria may apply
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8337 |
| CCMO | NL71886.056.19 |
| OMON | NL-OMON50062 |