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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05019105




Registration number
NCT05019105
Ethics application status
Date submitted
16/08/2021
Date registered
24/08/2021
Date last updated
2/09/2022

Titles & IDs
Public title
Phase 1 ALKS 1140 in Healthy Adults
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Escalating Doses of ALKS 1140 With a Pilot Evaluation of Food Effect in Healthy Adult Subjects
Secondary ID [1] 0 0
ALKS 1140-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Central Nervous System Diseases 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - ALKS 1140

Placebo Comparator: Placebo - Placebo administered orally

Active Comparator: ALKS 1140 - Up to 8 single ascending doses of ALKS 1140 and 4 multiple ascending doses administered orally


Treatment: Drugs: Placebo
Oral matching placebo

Treatment: Drugs: ALKS 1140
Active oral dose of ALKS 1140
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of treatment-emergent adverse events
Timepoint [1] 0 0
Up to 28 days
Primary outcome [2] 0 0
Change in Columbia-Suicide Severity Rating Scale (C-SSRS)
Timepoint [2] 0 0
Up to 28 days
Primary outcome [3] 0 0
12-lead safety ECG results
Timepoint [3] 0 0
Up to 28 days
Secondary outcome [1] 0 0
Maximum plasma concentration (Cmax) for ALKS 1140
Timepoint [1] 0 0
Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29
Secondary outcome [2] 0 0
Time to Cmax (Tmax)
Timepoint [2] 0 0
Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29
Secondary outcome [3] 0 0
Half-life (t1/2) of ALKS 1140
Timepoint [3] 0 0
Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours
Secondary outcome [4] 0 0
Time until first quantifiable concentration (tlag)
Timepoint [4] 0 0
Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29
Secondary outcome [5] 0 0
Area under the concentration-time curve (AUC)
Timepoint [5] 0 0
Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29
Secondary outcome [6] 0 0
Apparent volume of distribution at terminal phase (Vz/F)
Timepoint [6] 0 0
Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29
Secondary outcome [7] 0 0
Apparent total clearance following oral administration (CL/F)
Timepoint [7] 0 0
Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and Day 29
Secondary outcome [8] 0 0
Change from baseline in QTcF (Fridericia method) interval in response to treatment (Holter monitoring)
Timepoint [8] 0 0
Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and Day 29
Secondary outcome [9] 0 0
Accumulation Index (RA)
Timepoint [9] 0 0
Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and Day 29

Eligibility
Key inclusion criteria
- Body mass index (BMI) =18 and <30 kg/m2
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Clinically significant illness or disease including significant cardiac,
gastrointestinal (stomach)

- Subjects who have known allergic reactions to food or medications

- Women of childbearing potential

- Any clinically significant lifetime history of suicidal behavior or ideation
(thoughts)

- Subject had lymphoma, leukemia, or any malignancy within the past 5 years

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/08/2022
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Alkermes Clinical Investigative Site - Brisbane
Recruitment postcode(s) [1] 0 0
- Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Alkermes, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To evaluate the safety and tolerability of ALKS 1140 in healthy adult subjects
Trial website
https://clinicaltrials.gov/ct2/show/NCT05019105
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05019105