A Study to Evaluate the Pharmacokinetics of Dexlansoprazole 30 Milligram (mg) and 60 mg Delayed-release Capsules in Healthy Chinese Participants

Healthy Volunteers Clinical Trial

Official title:

A Phase 1, Single-Center, Open-Label, 2-Arm Parallel Group, Single-Dose Study to Evaluate the Pharmacokinetics of Dexlansoprazole 30 mg and 60 mg Delayed-Release Capsules in Healthy Chinese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03316976
• Other study ID #: TAK-390MR_106
• Secondary ID: U1111-1192-7711C
• Status: Completed
• Phase: Phase 1
• Start date: November 22, 2017
• Est. completion date: February 8, 2018

Study information

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

Clinical Trial Summary

The purpose of this study is to assess the pharmacokinetics after a single dose of dexlansoprazole 30 and 60 mg delayed-release capsules in healthy Chinese participants.

Description:

The drug being tested in this study is called Dexlansoprazole. This study will assess the pharmacokinetics, safety and tolerability of a single oral dose of Dexlansoprazole 30 mg and 60 mg delayed-release capsules in healthy participants.

The study will enroll approximately 40 participants, 20 participants in each parallel arm. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups:

• Group 1: A single oral dose of Dexlansoprazole 30 mg delayed-release capsule

• Group 2: A single oral dose of Dexlansoprazole 60 mg delayed-release capsule

All participants will be asked to take single dose of study drug on Day 1.

This single center trial will be conducted in China. The overall time to participate in this study is approximately 40 days. Participants will be contacted by telephone or will make a final visit to the clinic 5 to 10 days after receiving their last dose of study drug for a follow-up assessment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 8, 2018
• Est. primary completion date: February 8, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Is a healthy adult man or woman of Chinese descent.

2. Is aged 18 to 45 years, inclusive, at the time of informed consent and study medication dose.

3. Weighs at least 50 kilogram (kg) and has a body mass index (BMI) from 19.0 to 26.0 kilogram per square meter (kg/m^2), inclusive at Screening Visit.

Exclusion Criteria:

1. Has a known hypersensitivity to any component of the formulation of dexlansoprazole or other drug with the same mechanism of action (including lansoprazole, omeprazole, esomeprazole, rabeprazole, ilaprazole, or pantoprazole), or related compounds.

2. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the Screening visit or is unwilling to agree to abstain from alcohol for 48 hours prior to Check-in (Day -1) throughout the confinement and for 48 hours prior to each clinic visit and drugs throughout the study.

3. Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to Check-in (Day -1) or is unwilling to abstain from these products for the duration of the study.

4. Has poor peripheral venous access.

5. Has donated blood products (such as plasma), whole blood or had a significant blood loss (450 millimeter [mL]) within 56 days of Day 1.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Dexlansoprazole
Dexlansoprazole delayed-release capsule.

Locations

Country	Name	City	State
China	Phase I Clinical Trial Department	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole		Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose
Primary	AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Dexlansoprazole		Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose
Primary	AUC8: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Dexlansoprazole		Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose