Phase 1 ALKS 1140 in Healthy Adults

Central Nervous System Diseases Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05019105
• Other study ID #: ALKS 1140-001
• Status: Terminated
• Phase: Phase 1
• Start date: October 13, 2021
• Est. completion date: August 23, 2022

Study information

• Verified date: August 2022
• Source: Alkermes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: August 23, 2022
• Est. primary completion date: August 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Nervous System Diseases
• Nervous System Diseases

Intervention

Drug:
• Placebo
Oral matching placebo
• ALKS 1140
Active oral dose of ALKS 1140

Locations

Country	Name	City	State
Australia	Alkermes Clinical Investigative Site	Brisbane

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events		Up to 28 days
Primary	Change in Columbia-Suicide Severity Rating Scale (C-SSRS)	Change in C-SSRS measured in Multiple-Ascending Dose subjects only	Up to 28 days
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Accumulation Index (RA)		Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and Day 29