An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania

Neurocrine Biosciences

Status and phase: Not yet enrolling; Phase 2

Conditions: Bipolar I Disorder; Mania

Treatments: Drug: NBI-1117568; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07288320

NBI-1117568-BPD2036

Details and patient eligibility

About

The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving manic symptoms in adults with bipolar I disorder who are currently experiencing an episode of mania with or without mixed features.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Participant has a primary diagnosis of bipolar I disorder.
• The participant has had at least 1 prior documented manic episode that required treatment.
• The participant is experiencing an acute manic episode or manic episode with mixed features, with or without psychotic symptoms.

Key Exclusion Criteria:

• Any unstable or poorly controlled medical condition or chronic disease (including history of neurological, hepatic, renal, cardiovascular, gastrointestinal, pulmonary, autoimmune, or endocrine disease that may affect study participation or results), or malignancy within 90 days before the start of screening.
• Primary diagnosis is not bipolar I disorder.
• History of clozapine treatment for treatment-resistant psychosis.
• History of psychiatric hospitalization(s) for ≥30 consecutive days during the 90 days before the start of screening.

Note: Additional inclusion/exclusion criteria may apply, per protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups, including a placebo group

NBI-1117568

Experimental group

Description:

Participants will receive NBI-1117568.

Treatment:

Drug: NBI-1117568

Placebo

Placebo Comparator group

Description:

Participants will receive placebo matching NBI-1117568.

Treatment:

Drug: Placebo