Phase 1 TAK-041 First-in-Human Safety, Tolerability, and Pharmacokinetics Study

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers, Schizophrenia

In brief

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of TAK-041: 1. Following oral single and multiple doses in healthy participants. 2. As add-on therapy to antipsychotics in stable schizophrenia participants. 3. To determine the oral bioavailability of the TAK-041 tablet formulation compared to the oral suspension formulation in the fasted state. 4. To assess the effect of food on the PK of TAK-041 in healthy participants.

Key facts

Study ID

NCT02748694

Run by

Neurocrine Biosciences

People needed

114

Starts

2016-05-09

Expected to finish

2019-09-22

Last updated by the study team

2021-03-19

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy Participants and Participants with Schizophrenia:
• In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
• The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any participant procedures including requesting that a participant fast for any laboratory evaluations.
• The participant is willing to comply with study restrictions described in the protocol.
• The participant is a healthy adult man or woman (of non-childbearing potential as described in the protocol)
• The participant is aged 18 to 55 years, inclusive, at the time of informed consent.
• The participant weighs at least 45 kilogram (kg) (99 pound [lb]) with a body mass index from 18 to 32 kilogram per square meter (kg/m\^2) for healthy participants and up to 40.5 kg/m\^2 for participants with schizophrenia, inclusive at screening.
• A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception (as defined in the protocol)from signing of informed consent throughout the duration of the study and for 145 days have elapsed since the last dose of study drug.
• Participants with schizophrenia only-:
• Is on a stable dose of an antipsychotic medication for at least 2 months as documented by medical history and assessed by site staff.
• Meets schizophrenia criteria as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) by the Mini International Neuropsychiatric Interview (MINI).
• Has Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 90 and PANSS Negative Symptom Factor Score (NSFS; Sum of PANSS N1, N2, N3, N4, N6, G7, and G16) greater than or equal to (>=) 15 at screening and baseline (Day-1).
• Has stable screening and baseline (Day -1) PANSS and NSFS total scores (less than [<] 20 percent (%) change).

You may not qualify if…

• Healthy Participants:
• The participant has received any investigational compound within 30 days prior to the first dose of study drug, or due to the half-life of the investigational drug is likely to still have detectable plasma levels of that compound.
• The participant is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (example spouse, parent, child, sibling) or may consent under duress
• The participant has a known hypersensitivity to any component of the formulation of TAK-041.
• The participant has a positive urine/blood drug result for drugs of abuse (defined as any illicit drug use) at Screening or Check-in (Day -1).
• The participant taken any excluded medication, supplements, or food products during the time periods listed in the protocol.
• The participant is lactose intolerant (Part3 only).
• If female, the participant is of childbearing potential (example, premenopausal, not sterilized).
• If male, the participant intends to donate sperm during the course of this study or for 145 days have elapsed since the last dose of study drug.
• The participant has evidence of current active cardiovascular, central nervous system, hepatobiliary disease including history of biliary tree disorders, gallstones, endoscopic retrograde cholangio pancreatography (ERCP), and/or cholecystectomy, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma, hypoxemia, hypertension, seizures, or allergic skin rash. There is any finding in the participant's medical history, physical examination, or safety laboratory test results (including elevated alkaline phosphatase (ALP), elevated bilirubin, elevated GGT, or elevated 5'-nucleotidase) that in the judgment of the principal investigator represents a reasonable suspicion of a disease that would contraindicate taking TAK-041, or that might interfere with the conduct of the study. This includes, but is not limited to, peptic ulcer disease, cholestasis, seizure disorders, and cardiac arrhythmias.
• The participant has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (that is, a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent [more than once per week] occurrence of heartburn, or any surgical intervention).
• Had major surgery, or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to Screening.
• The participant has a history of cancer, except basal cell carcinoma that has been in remission for at least 5 years prior to Day 1. Participant has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody at Screening or a known history of human immunodeficiency virus (HIV) infection.
• The participant has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 21 days prior to Check-in on Day -1. Cotinine test is positive at Screening or Day -1.
• The participant has poor peripheral venous access.
• Had a transfusion of any blood product within 30 days prior to Day 1.
• Participant has a Screening or Check-in abnormal (clinically significant) electrocardiogram (ECG). Entry of any participant with an abnormal (not clinically significant) ECG must be approved, and documented by signature of the principal investigator or a medically qualified sub-investigator.
• The participant has a sustained resting heart rate outside the range 40 to 100 beats per minute (bpm), confirmed on repeat testing within a maximum of 30 minutes, at Screening or Check-in.
• The participant has a QT interval with Fridericia correction method (QTcF) >450 millisecond (ms) or PR outside the range 120 to 220 ms, confirmed on repeat testing within a maximum of 30 minutes, at the Screening Visit or Check-in.
• The participant has abnormal Screening or Check-in laboratory values (> upper limit of normal [ULN] for the respective serum chemistries) of alanine transaminase (ALT), aspartate aminotransferase (AST), total bilirubin (TBILI), ALP, gamma-glutamyl transpeptidase (GGT), 5'nucleotidase (Screening only) and/or abnormal urine osmolality, confirmed upon repeat testing.
• The participant has a clinically significant history of head injury or trauma associated with loss of consciousness for >15 minutes.
• Is considered by the investigator to be at an imminent risk of suicide injury to self, other, property, or participants who within the past year prior to Screening have attempted suicide. Participants having positive answer on item 4 or 5 on Columbia Suicide Severity Rating Scale (C-SSRS) (based on the past year) prior to randomization are excluded.
• The participant has a history of significant skin reactions (hypersensitivity) to adhesives, metals or plastic; this criterion applies only to participants participating in the study of the two wearable digital devices.
• Participants with schizophrenia only:
• Has an undetectable level of baseline antipsychotic medication at Screening.

Where it is running

• Parexel Early Phase Clinic Unit- Los Angeles — Glendale, California, United States

Full record on ClinicalTrials.gov

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