A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Ascending Oral Single Dose of TAK-418 in Healthy Participants

Healthy Participants Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Ascending Oral Single Dose Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAK-418 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03228433
• Other study ID #: TAK-418-1001
• Secondary ID: U1111-1195-7777
• Status: Completed
• Phase: Phase 1
• Start date: July 21, 2017
• Est. completion date: May 12, 2018

Study information

• Verified date: August 2019
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability of TAK-418 following single oral doses in healthy participants.

Description:

The drug being tested in this study is called TAK-418. TAK-418 is being tested in healthy participants in order to evaluate the safety, tolerability, and pharmacokinetics (PK) of single oral doses.

The study will enroll approximately 40 healthy participants. The study consists of equally divided 5 sequential cohorts of 8 participants each. In each of the following cohorts, 6 participants will be randomized to receive TAK-418 and 2 participants will receive matching placebo—which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):

• Cohort 1: TAK-418 5 mg

• Cohort 2: TAK-418 15 mg

• Cohort 3: TAK-418 30 mg Fasted + TAK-418 30 mg Fed

• Cohort 4: TAK-418 40 mg

• Cohort 5: TAK-418 60 mg

All participants will be asked to take TAK-418 or placebo-matching capsule once on Day 1 in each cohort. A washout period of 28-days will be maintained between the doses in Cohort 3.

This single center trial will be conducted in the United States. Participants in this study will be assigned to one of 5 possible dose cohorts. Male participants will return for additional outpatient visits on Days 91 and 93 (+/- 7 days) and may return for outpatient visits on Days 182 and 184 (+/- 7 days) (depending on results from the Day 93 Visit).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 12, 2018
• Est. primary completion date: May 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Is a male or female participants with a body mass index (BMI) within the range of 18.5 -30.0 kilogram per square meter (kg/m^2) at the Screening Visit.

2. Is a nonsmoker who has not used tobacco or nicotine-containing products (example, nicotine patch) for at least 6 months before trial drug administration of the initial dose of trial drug or invasive procedure.

3. Must be judged to be in good health by the investigator, based on clinical evaluations including laboratory safety tests, medical history, physical examination, 12-lead ECG, and vital sign measurements performed at the Screening Visit and before administration of the initial dose of trial drug or invasive procedure as per principal investigator's judgment.

4. Female subjects with no childbearing potential, defined by at least 1 of the following criteria:

• Postmenopausal (defined as 12 months of spontaneous amenorrhea in women aged greater than [>]45 years, 6 months of spontaneous amenorrhea in women aged >45 years with serum follicle-stimulating hormone [FSH] levels >40 milli-international units per milliliter [mIU/mL]). Appropriate documentation of FSH levels is required.

• Surgically sterile by hysterectomy and/or bilateral oophorectomy with appropriate documentation of surgical procedure.

• Had a tubal ligation with appropriate documentation of surgical procedure.

• Has a congenital condition resulting in no uterus.

Exclusion Criteria:

1. Has had major surgery, donated or lost 1 unit of blood (approximately 500 milliliter [mL]) within 4 weeks before the Screening Visit.

2. Has a risk of suicide according to the investigator's clinical judgment per the Columbia-Suicide Severity Rating Scale at Screening or has made a suicide attempt in the 6 months before Screening.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• TAK-418
TAK-418 Capsule.
• TAK-418 Placebo
TAK-418 placebo-matching capsules.

Locations

Country	Name	City	State
United States	PAREXEL International	Glendale	California

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)		Baseline Up to Day 184
Primary	Number of Participants Who Discontinued Due to an Adverse Event (AE)		Baseline Up to Day 184
Primary	Number of Participants Who Meet the Markedly Abnormal Criteria for Neurological Assessment Measurements at Least Once Post Dose		Baseline Up to Day 184
Primary	Number of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose		Baseline Up to Day 184
Primary	Number of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose		Baseline Up to day 184
Primary	Number of Participants Who Meet the Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose		Baseline Up to Day 14
Secondary	AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration of TAK-418F (TAK-418 Free Base)		Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Secondary	AUC8: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-418F		Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Secondary	Cmax: Maximum Observed Plasma Concentration for TAK-418F		Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Secondary	Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-418F	The pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least one measurable plasma concentration or amount of drug in urine for TAK-418-F.	Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose