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Phase 1 ALKS 1140 in Healthy Adults

Primary Purpose

Central Nervous System Diseases

Status

Terminated

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

Placebo

ALKS 1140

About this trial

This is an interventional treatment trial for Central Nervous System Diseases

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Alkermes Clinical Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

ALKS 1140

Arm Description

Placebo administered orally

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

Outcomes

Primary Outcome Measures

Incidence of treatment-emergent adverse events

Change in Columbia-Suicide Severity Rating Scale (C-SSRS)

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

12-lead safety ECG results

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

Maximum plasma concentration (Cmax) for ALKS 1140

Time to Cmax (Tmax)

Half-life (t1/2) of ALKS 1140

Time until first quantifiable concentration (tlag)

Area under the concentration-time curve (AUC)

Apparent volume of distribution at terminal phase (Vz/F)

Apparent total clearance following oral administration (CL/F)

Change from baseline in QTcF (Fridericia method) interval in response to treatment (Holter monitoring)

Accumulation Index (RA)

Full Information

NCT ID

NCT05019105

First Posted

August 16, 2021

Last Updated

August 31, 2022

Sponsor

Alkermes, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05019105

Brief Title

Phase 1 ALKS 1140 in Healthy Adults

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Terminated

Why Stopped

Sponsor Decision

Study Start Date

October 13, 2021 (Actual)

Primary Completion Date

August 23, 2022 (Actual)

Study Completion Date

August 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alkermes, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Central Nervous System Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo administered orally

Arm Title

ALKS 1140

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral matching placebo

Intervention Type

Drug

Intervention Name(s)

ALKS 1140

Intervention Description

Active oral dose of ALKS 1140

Primary Outcome Measure Information:

Title

Incidence of treatment-emergent adverse events

Time Frame

Up to 28 days

Title

Change in Columbia-Suicide Severity Rating Scale (C-SSRS)

Description

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

Time Frame

Up to 28 days

Title

12-lead safety ECG results

Description

Time Frame

Up to 28 days

Secondary Outcome Measure Information:

Title

Maximum plasma concentration (Cmax) for ALKS 1140

Time Frame

Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29

Title

Time to Cmax (Tmax)

Time Frame

Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29

Title

Half-life (t1/2) of ALKS 1140

Time Frame

Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours

Title

Time until first quantifiable concentration (tlag)

Time Frame

Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29

Title

Area under the concentration-time curve (AUC)

Time Frame

Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29

Title

Apparent volume of distribution at terminal phase (Vz/F)

Time Frame

Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29

Title

Apparent total clearance following oral administration (CL/F)

Time Frame

Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and Day 29

Title

Change from baseline in QTcF (Fridericia method) interval in response to treatment (Holter monitoring)

Time Frame

Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and Day 29

Title

Accumulation Index (RA)

Time Frame

Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and Day 29

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Alkermes Clinical Investigative Site

City

Brisbane

Country

Australia

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Phase 1 ALKS 1140 in Healthy Adults

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