Primary:* Evaluate the safety and tolerability of ALKS 7119 following oral administration of multiple ascending doses of ALKS 7119 in healthy male and female adultsSecondary:* Evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of ALKS 7119…
ID
Source
Brief title
Condition
- Neurological disorders NEC
- Dementia and amnestic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety and tolerability: 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.
Secondary outcome
Pharmacokinetics: Concentrations of ALKS 7119 will be quantified in plasma
samples collected for PK evaluation. Noncompartmental PK analyses will be
performed to estimate the PK parameters.
At a minimum, the following PK parameters will be determined for ALKS 7119, as
applicable:
* Maximum plasma concentration (Cmax) of ALKS 7119 on Day 1 and Day 14
* Area under the concentration-time curve from time zero to the last
quantifiable time interval (AUClast) on Day 1 and Day 14
* Area under the concentration-time curve over the 24-hour dosing interval
(AUC24h) of ALKS 7119 on Day 1 and Day 14
* Area under the concentration-time curve from time zero to infinity (AUC*)
after the first dose on Day 1
* Time to Cmax (tmax) of ALKS 7119 on Day 1 and Day 14
* Terminal elimination half-life (t*) of ALKS 7119 on Day 1 and Day 14
* Trough plasma concentration (Ctrough) on Day 1 through Day 14
* Accumulation ratio (Day 14/Day 1 AUC24h ratio)
Dose proportionality assessment and additional PK analyses may be performed as
appropriate.
Background summary
Emerging studies point to a potential role for NMDA antagonists in treating
behavioral symptoms associated with Alzheimer*s
disease, including agitation [Cummings, 2014;Wilcock, 2008]. There are
currently no approved drugs in the US for treating these
symptoms, which diminish quality of life for patients and caretakers and
correlate with a poorer disease prognosis. Developing drugs
for this indication therefore represents a significant clinical need. As a
low-affinity antagonist at the NMDA receptor, Alkermes
postulates that ALKS 7119 may be applicable for this purpose.
Study objective
Primary:
* Evaluate the safety and tolerability of ALKS 7119 following oral
administration of multiple ascending doses of ALKS 7119 in healthy male and
female adults
Secondary:
* Evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of ALKS 7119
following oral administration of multiple ascending doses of ALKS 7119 in
healthy male and female adults
Study design
This is a Phase 1, single-center, randomized, double-blind, placebo-controlled,
MAD study of ALKS 7119 in healthy adults. This study will evaluate the safety,
tolerability, PK, and PD of ALKS 7119 following multiple ascending doses. The
study will include at least 4 cohorts, with each cohort representing a
different dose level. Gender will be approximately equally balanced across
cohorts (with a minimum of one-third female subjects).
Potential subjects will be screened up to 21 days prior to administration of
study drug. Dosing of cohorts will be separated by at least
7 days to allow adequate time for a review of all safety, PD, and PK data from
the most recently dosed cohort.
The study duration for a given subject is expected to be up to 6 weeks, which
includes up to 3 weeks for screening, an inpatient
stay from Day -1 to Day 215 and a follow-up visit on Day 21 (+3 days).
Intervention
The subjects will receive multiple doses of ALKS 7119 or placebo.
Study burden and risks
There is no health benefit for participants. Risk is considered minimal. Burden
consists of time investment and life style restrictions.
Winter Street 852 -
Waltham MA 02451
US
Winter Street 852 -
Waltham MA 02451
US
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-001905-18-NL |
| CCMO | NL57772.056.16 |