Safety Study of ACP-104: To Demonstrate the Safety, Tolerability, and Pharmacokinetics
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the safety and tolerability of ACP-104 after oral administration of single doses
      in comparison with placebo to schizophrenia or other psychotic disorders.
    

Detailed description: 
      Thirty-six healthy patients with schizophrenia or psychotic disorders, each of whom will be
      drug-free at study initiation, will be admitted to the hospital and will each receive two
      doses of ACP-104, and one dose of placebo, orally every 3-5 days over a two-week period. The
      patients will be divided into six groups of up to six and minimum of 3 patients each. Group 1
      will consist of six patients who will receive single 25mg and 50mg doses of ACP-104 and
      placebo in random, but rising dose, order over a two-week period. Data from group one will be
      collected to determine ACP-104's safety, tolerability, and pharmacokinetics. Group 2 will be
      enrolled in the study once study data from Group 1 has demonstrated the safety of ACP-104.
      Group 2 will receive a 25mg pre-conditioning dose of ACP-104. Following the pre-conditioning
      dose, 75mg and 100mg single doses of ACP-104 will be administered in random, but rising dose,
      order, over a two-week period. Group 3 will be enrolled in the study once study data from
      Group 2 has demonstrated the safety of ACP-104. Group 3 will receive a 25mg pre-conditioning
      dose of ACP-104. Following the pre-conditioning dose, 125mg and 150mg single doses of ACP-104
      will be administered in random, but rising dose, order, over a two-week period. Group 4 will
      be enrolled in the study once study data from Group 3 has demonstrated the safety of ACP-104.
      Group 4 will receive a 25mg pre-conditioning dose of ACP-104. Following the pre-conditioning
      dose, 175mg and 200mg single doses of ACP-104 will be administered in random, but rising
      dose, order, over a two-week period. Group 5 will be enrolled in the study once study data
      from Group 4 has demonstrated the safety of ACP-104. Group 5 will receive a 25mg
      pre-conditioning dose of ACP-104. Following the pre-conditioning dose, 225mg and 250mg single
      doses of ACP-104 will be administered in random, but rising dose, order, over a two week
      period. Group 6 will be enrolled in the study once study data from Group 5 has demonstrated
      the safety of ACP-104. Group 6 will receive a 25mg pre-conditioning dose of ACP-104.
      Following the pre-conditioning dose, 275mg and 300mg single doses of ACP-104 will be
      administered in random, but rising dose, order, over a two-week period. Groups 1-6 will be
      monitored closely and safety procedures and evaluations will be performed on all medication
      days. Safety assessments will include: physical examinations, vital signs (3-positional blood
      pressure and pulse rate, respiration rate, and oral body temperature), clinical laboratory
      tests, ECGs (Electrocardiogram), coordination tests, questions about symptoms and side
      effects. Once all medication days have been completed, the condition of the patient will be
      assessed, and, at that time, it will be determined whether the patient's condition is
      suitable for release from the hospital or whether further monitoring of the patient's
      condition as an inpatient is needed.
    

Intervention name(s): ACP-104; ACP-104; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 25mg, 75mg, 125mg, 175mg, 225mg, or 275mg once a day for 2 weeks; Patient will be given either 50mg, 100mg, 150mg, 200mg, 250mg, or 300mg daily for 2 weeks; patients will be given a placebo: 25mg, 50mg, 75mg, 100mg, 125mg, 150mg, 175mg, 200mg, 225mg, 250mg, 275mg, or 300mg (to match the doses given) daily for 2 weeks.
Other intervention name(s): cornstarch capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Schizophrenia; N-desmethylclozapine; clozapine; psychosis; randomized; placebo studies