Clincosm LogoSign in Get a demo

Phase 1 ALKS 1140 in Healthy Adults

Sponsor
Alkermes, Inc. (Industry)
Overall Status
Suspended
CT.gov ID
NCT05019105
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
11.6
Anticipated Duration (Months)
6.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the safety and tolerability of ALKS 1140 in healthy adult subjects

Condition or Disease Intervention/Treatment Phase
  • Drug: Placebo
  • Drug: ALKS 1140
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Oct 13, 2021
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Placebo administered orally

Drug: Placebo
Oral matching placebo
Active Comparator: ALKS 1140

Up to 8 single ascending doses of ALKS 1140 and 4 multiple ascending doses administered orally

Drug: ALKS 1140
Active oral dose of ALKS 1140

Outcome Measures

Primary Outcome Measures

  1. Incidence of treatment-emergent adverse events [Up to 28 days]

  2. Change in Columbia-Suicide Severity Rating Scale (C-SSRS) [Up to 28 days]

    Change in C-SSRS measured in Multiple-Ascending Dose subjects only

  3. 12-lead safety ECG results [Up to 28 days]

    ECG parameters (Heart Rate, RR, PR, QRS, QT, QTcF, T wave) will be analysed using descriptive summary statistics (mean, standard deviation, median, minimum, and maximum for continuous variables) and as a change from baseline by dose level and treatment group. For the QT interval assessment, clinically abnormal ECG results for QTcF will be tabulated by protocol-specified millisecond range categories by dose and treatment group. Potentially clinically significant findings will be summarized by dose and treatment group.

Secondary Outcome Measures

  1. Maximum plasma concentration (Cmax) for ALKS 1140 [Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29]

  2. Time to Cmax (Tmax) [Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29]

  3. Half-life (t1/2) of ALKS 1140 [Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours]

  4. Time until first quantifiable concentration (tlag) [Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29]

  5. Area under the concentration-time curve (AUC) [Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29]

  6. Apparent volume of distribution at terminal phase (Vz/F) [Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29]

  7. Apparent total clearance following oral administration (CL/F) [Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and Day 29]

  8. Change from baseline in QTcF (Fridericia method) interval in response to treatment (Holter monitoring) [Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and Day 29]

  9. Accumulation Index (RA) [Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and Day 29]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Body mass index (BMI) ≥18 and <30 kg/m2
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Alkermes Clinical Investigative Site Brisbane Australia

Sponsors and Collaborators

  • Alkermes, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alkermes, Inc.
ClinicalTrials.gov Identifier:
NCT05019105
Other Study ID Numbers:
  • ALKS 1140-001
First Posted:
Aug 24, 2021
Last Update Posted:
Mar 3, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Nervous System Diseases
Central Nervous System Diseases

Study Results

No Results Posted as of Mar 3, 2022