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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05019105

Enrollment

Registered

2021-08-24

Start date

2021-10-13

Completion date

2022-08-23

Last updated

2022-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Nervous System Diseases

Brief summary

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

Interventions

DRUGALKS 1140

Active oral dose of ALKS 1140

DRUGPlacebo

Oral matching placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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
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

Measure	Time frame
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
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
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
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
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

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026