Phase 1 ALKS 1140 in Healthy Adults

NCT05019105 | Terminated Phase 1

• 1 other identifier: ALKS 1140-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Central Nervous System Diseases

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo administered orally

Drug: Placebo

ALKS 1140

ACTIVE COMPARATOR

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

Drug: ALKS 1140

Interventions

Placebo DRUG

Oral matching placebo

Placebo

ALKS 1140 DRUG

Active oral dose of ALKS 1140

ALKS 1140

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index (BMI) ≥18 and \<30 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Alkermes, Inc.: lead

Study Sites (1)

Alkermes Clinical Investigative Site

Brisbane, Australia

Location

MeSH Terms

Conditions

Central Nervous System Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 24, 2021
• Study Start: October 13, 2021
• Primary Completion: August 23, 2022
• Study Completion: August 23, 2022
• Last Updated: September 2, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)