Phase 1 ALKS 1140 in Healthy Adults

Alkermes

Status and phase: Terminated; Phase 1

Conditions: Central Nervous System Diseases

Treatments: Drug: ALKS 1140; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05019105

ALKS 1140-001

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo administered orally

Treatment:

Drug: Placebo

ALKS 1140

Active Comparator group

Description:

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

Treatment:

Drug: ALKS 1140