Trials Sponsors Conditions Drugs Pricing

Conditions

Healthy Volunteers Schizophrenia

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (8)

Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug or due to a study procedure; it did not necessarily have to have a causal relationship with this treatment. A TEAE was defined as an AE that occurred or worsened after receiving the first dose of study drug and within 6 weeks after the last dose of study drug. A TEAE may also have been a pre-treatment AE or a concurrent medical condition diagnosed before the date of first dose of study drug that increased in severity after the start of dosing.
From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks)
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug or due to a study procedure; it did not necessarily have to have a causal relationship with this treatment.
From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks)
Percentage of Participants With Markedly Abnormal Value (MAV) Criteria for Safety Laboratory Tests At Least Once Post-dose
Clinical laboratory tests included serum chemistry, hematology and urinalysis. MAV criteria:Alanine aminotransferase(U/L) \>3 x upper limit of normal(ULN);albumin\<2.5g/dL,\<25g/L;alkaline phosphatase (U/L)\>3 x ULN; aspartate aminotransferase (U/L)\>3 x ULN;bicarbonate\<8.0 mmol/L; bilirubin\>2.0mg/dL, \>34.2 μmol/L;blood urea nitrogen\>30 mg/dL,\>10.7mmol/L;calcium\<7.0 mg/dL,\<1.75 mmol/L, \>11.5 mg/dL,\>2.88 mmol/L;chloride\<75 mmol/L,\>126 mmol/L;creatine kinase(U/L) \>5 xULN; creatinine\>2.0 mg/dL,\>177μmol/L;direct bilirubin\>2 x ULN;gamma glutamyl transferase (U/L)\>3 x ULN;glucose\<50 mg/dL,\<2.8 mmol/L,\>350 mg/dL,\>19.4 mmol/L;potassium\<3.0 mmol/L \>6.0 mmol/L; protein(g/L)\<0.8 x LLN \>1.2 x ULN;sodium\<130mmol/L \>150mmol/L;erythrocytes(10\^12erythrocytes/L) \<0.8 x LLN,\>1.2 x ULN;hematocrit(fraction of 1)\<0.8 x LLN,\>1.2xULN;hemoglobin(g/L)\<0.8 x LLN\>1.2 x ULN;leukocytes(10\^9 leukocytes/L)\<0.5 x LLN \>1.5 x ULN;platelets(10\^9 platelets/L)\<75-\>600. Categories with at least one participant are reported.

Secondary Outcomes (24)

Part 1: Cmax: Maximum Observed Plasma Concentration for TAK-041 in SRD Participants [Day 1]
Part 1: Day 1 pre-dose and at multiple time points post dose, up to 96 hours for Cohorts 1 and 2; up to 168 hours for Cohorts 3-5
Part 1: Cmax: Maximum Observed Plasma Concentration for TAK-041 in SRD Participants [Day 8], Cohorts 1 (20 mg) and 2 (40 mg) Only
Part 1: Pre-dose on Day 8 and at multiple timepoints (Up to 96 hours) post-dose
Parts 2 and 4: Cmax: Maximum Observed Plasma Concentration for TAK-041 in MRD Participants [Day 1]
Parts 2 and 4: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Part 1: Tmax: Time to Reach the Cmax for TAK-041 in SRD Participants [Day 1]
Part 1: Day 1 pre-dose and at multiple time points post dose, up to 96 hours for Cohorts 1 and 2; up to 168 hours for Cohorts 3-5
Part 1: Tmax: Time to Reach the Cmax for TAK-041 in SRD Participants [Day 8], Cohorts 1 (20 mg) and 2 (40 mg) Only
Part 1: Pre-dose on Day 8 and at multiple timepoints (Up to 96 hours) post-dose

Study Arms (15)

Part 1 (SRD): Placebo Cohorts 1-5

PLACEBO COMPARATOR

TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.

Drug: TAK-041 Placebo

Part 1 (SRD): Cohort 1: TAK-041 5/20 mg

EXPERIMENTAL

TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period. Participants also received 20 mg, suspension, orally, once on Day 8 in the SRD period.

Drug: TAK-041

Part 1 (SRD): Cohort 2: TAK-041 10/40 mg

EXPERIMENTAL

TAK-041 10 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period. Participants also received 40 mg, suspension, orally, once on Day 8 in the SRD period.

Interventions

TAK-041Drug

TAK-041 tablets or oral suspension.

Part 1 (SRD): Cohort 1: TAK-041 5/20 mgPart 1 (SRD): Cohort 2: TAK-041 10/40 mgPart 1 (SRD): Cohort 3: TAK-041 80 mgPart 1 (SRD): Cohort 4: TAK-041 120 mgPart 1 (SRD): Cohort 5: TAK-041 160 mgPart 2 (MRD): Cohort 1: TAK-041 40/20 mgPart 2 (MRD): Cohort 2: TAK-041 80/40 mgPart 2 (MRD): Cohort 3: TAK-041 120/60 mgPart 2 (MRD): Cohort 4: TAK-041 160/80 mgPart 3: RBA/Food Effect: Regimen B

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

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.

Sponsors & Collaborators

Neurocrine Biosciences
Industrylead
Takeda
Industrycollaborator

Study Sites (1)

Parexel Early Phase Clinic Unit- Los Angeles

Glendale, California, 91206, United States

Related Publications (1)

Yin W, Han D, Khudyakov P, Behrje R, Posener J, Laurenza A, Arkilo D. A phase 1 study to evaluate the safety, tolerability and pharmacokinetics of TAK-041 in healthy participants and patients with stable schizophrenia. Br J Clin Pharmacol. 2022 Aug;88(8):3872-3882. doi: 10.1111/bcp.15305. Epub 2022 Apr 17.
PMID: 35277995DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

TAK-041

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Results Point of Contact

Title: Medical Director
Organization: Takeda

Study Officials

Medical Director Clinical Science
Takeda
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

114 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: OTHER
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 20, 2016

First Posted

April 22, 2016

Study Start

May 9, 2016

Actual (reported)

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.
+17 more criteria

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (8)

Secondary Outcomes (24)

Study Arms (15)

Part 1 (SRD): Placebo Cohorts 1-5

Part 1 (SRD): Cohort 1: TAK-041 5/20 mg

Part 1 (SRD): Cohort 2: TAK-041 10/40 mg

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Part 1 (SRD): Cohort 3: TAK-041 80 mg

Part 1 (SRD): Cohort 4: TAK-041 120 mg

Part 1 (SRD): Cohort 5: TAK-041 160 mg

Part 2 (MRD): Placebo Cohorts 1-4

Part 2 (MRD): Cohort 1: TAK-041 40/20 mg

Part 2 (MRD): Cohort 2: TAK-041 80/40 mg

Part 2 (MRD): Cohort 3: TAK-041 120/60 mg

Part 2 (MRD): Cohort 4: TAK-041 160/80 mg

Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A

Part 3: RBA/Food Effect: Regimen B

Part 4: MRD: Placebo

Part 4: MRD: TAK-041 160/80 mg

You may not qualify if:

Data Sharing

Source record

Documents

Locations