Phase 1 ALKS 1140 in Healthy Adults

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

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

Study Overview

• Status: Terminated
• Conditions: Central Nervous System Diseases
• Intervention / Treatment: Drug: Placebo; Drug: ALKS 1140

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Brisbane, Australia
    • Alkermes Clinical Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment-emergent adverse events		Up to 28 days
Change in Columbia-Suicide Severity Rating Scale (C-SSRS)	Change in C-SSRS measured in Multiple-Ascending Dose subjects only	Up to 28 days
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.	Up to 28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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
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
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
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
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
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
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
Accumulation Index (RA)	Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and Day 29

Collaborators and Investigators

• Sponsor: Alkermes, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2021
• Primary Completion (Actual): August 23, 2022
• Study Completion (Actual): August 23, 2022

Study Registration Dates

• First Submitted: August 16, 2021
• First Submitted That Met QC Criteria: August 20, 2021
• First Posted (Actual): August 24, 2021

Study Record Updates

• Last Update Posted (Actual): September 2, 2022
• Last Update Submitted That Met QC Criteria: August 31, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Central Nervous System Diseases
• Other Study ID Numbers: ALKS 1140-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No