Tolerability and Pharmacokinetics of Iloperidone in Adolescent Patients

Vanda Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Safety and Tolerability of Iloperidone

Treatments: Drug: iloperidone (oral tablet)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01495169

CILO522D2402

Details and patient eligibility

About

Tolerability, undertstanding of the action of the drug in the body, and understanding the effect of the drug in adolescent patients needing treatment with an antipsychotic medication

Enrollment: 33 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• males or females 12-17 years of age.
• in a stable housing situation with a guardian/parent who can encourage compliance with the study protocol.
• with diagnosis of disorder requiring treatment with an antipsychotic agent.
• having a Children's Global Assessment of Severity Scale (CGAS) of 41 or greater.
• Heart rate </=100 beats per minute and >/= 50 beats per minute.

Exclusion criteria

• Patients with mild, moderate or severe mental retardation (i.e., documented IQ <70), do not have the capacity to assent, cannot understand the informed consent, or participate fully in the assessments.
• Hospitalized due to suicidal ideation or suicidal behavior, history of suicidal ideation within 6 months prior to screening, history of suicidal behavior within 2 years prior to screening.
• Pregnant, females who can become pregnant and lactating females.
• Known hypersensitivity to iloperidone and to related drugs.
• Clinical conditions (Neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal or urological), which may pose significant risk to patients or impair reliable study participation.
• Clinically unstable cardiac disease, structural cardiac abnormalities, congential long QT syndrome, clinically significant ECG abnormalities at screening (PR interval >240 ms, QTcF >450 ms, QRS duration >/= 100 ms) or arrhythmias.
• Syncope, near syncope, or palpitations. Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Iloperidone

Experimental group

Description:

Part A (dose-escalation and fixed dose): Eligible patients receive iloperidone 2mg/day (1 mg BID) on day 1, then escalated every day for up to 12days utilizing a forced titration regimen to achieve a maximum dose of 12, 16, 20 or 24 mg/day given BID. Part B (optional extension phase): Patients who successfully complete Part A of the study are eligible to continue treatment with iloperidone for an additional 26 weeks

Treatment:

Drug: iloperidone (oral tablet)