Phase 1 ALKS 1140 in Healthy Adults

Phase 1

Terminated

• Conditions: Central Nervous System Diseases
• Interventions: Drug: ALKS 1140; Drug: Placebo

• Registration Number: NCT05019105
• Lead Sponsor: Alkermes, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-16
• Study First Submitted QC: 2021-08-20
• Study First Posted: 2021-08-24
• Study Start: 2021-10-13
• Status Verified: 2022-08
• Primary Completion: 2022-08-23
• Study Completion: 2022-08-23
• Last Update Submitted: 2022-08-31
• Last Update Posted: 2022-09-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALKS 1140	ALKS 1140	Up to 8 single ascending doses of ALKS 1140 and 4 multiple ascending doses administered orally
Placebo	Placebo	Placebo administered orally

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
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
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
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 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
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
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

Trial Locations

Locations (1)

Alkermes Clinical Investigative Site; 🇦🇺 Brisbane, Australia