NCT03316976

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 23, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

November 22, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2018

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

May 10, 2019

Completed
Last Updated

May 10, 2019

Status Verified

February 1, 2019

Enrollment Period

3 months

First QC Date

October 18, 2017

Results QC Date

February 8, 2019

Last Update Submit

February 8, 2019

Conditions

Healthy Volunteers

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (3)

  • Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole

    Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose

  • 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

  • AUC∞: 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

Study Arms (2)

Group 1: Dexlansoprazole 30 mg

EXPERIMENTAL

Dexlansoprazole 30 mg, delayed-release, capsule, orally, administered as single dose on Day 1.

Drug: Dexlansoprazole

Group 2: Dexlansoprazole 60 mg

EXPERIMENTAL

Dexlansoprazole 60 mg, delayed-release, capsule, orally, administered as single dose on Day 1.

Drug: Dexlansoprazole

Interventions

DexlansoprazoleDRUG

Dexlansoprazole delayed-release capsule.

Also known as: TAK-390 Modified Release (TAK-390MR) dexlansoprazole
Group 1: Dexlansoprazole 30 mgGroup 2: Dexlansoprazole 60 mg

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Is a healthy adult man or woman of Chinese descent.
  • Is aged 18 to 45 years, inclusive, at the time of informed consent and study medication dose.
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Phase I Clinical Trial Department

Beijing, Beijing Municipality, 100005, China

Location

MeSH Terms

Interventions

Dexlansoprazole

Intervention Hierarchy (Ancestors)

Lansoprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Medical Director
Organization
Takeda
trialdisclosures@takeda.com
+1-877-825-3327

Study Officials

  • Medical Director

    Takeda

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2017

First Posted

October 23, 2017

Study Start

November 22, 2017

Primary Completion

February 8, 2018

Study Completion

February 8, 2018

Last Updated

May 10, 2019

Results First Posted

May 10, 2019

Record last verified: 2019-02

Locations

CN(1)