Phase 1 ALKS 1140 in Healthy Adults

NCT ID: NCT05019105

Last Updated: 2022-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-13

Study Completion Date

2022-08-23

Brief Summary

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

Detailed Description

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Conditions

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Central Nervous System Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Placebo administered orally

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral matching placebo

ALKS 1140

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

Group Type ACTIVE_COMPARATOR

ALKS 1140

Intervention Type DRUG

Active oral dose of ALKS 1140

Interventions

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Placebo

Oral matching placebo

Intervention Type DRUG

ALKS 1140

Active oral dose of ALKS 1140

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alkermes, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Alkermes Clinical Investigative Site

Brisbane, , Australia

Site Status

Countries

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Australia

Other Identifiers

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ALKS 1140-001

Identifier Type: -

Identifier Source: org_study_id

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