A Study to Compare the Bioavailability (BA) of Dexlansoprazole Delayed-release Capsules

NCT03801148 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: TAK-390MR-1002U1111-1224-9781
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the BA of 30 or 60 milligram (mg) dexlansoprazole capsule manufactured at TOB (Takeda GmbH Plant Oranienburg) to the corresponding 30 or 60 mg dexlansoprazole manufactured at TPC (Takeda Pharmaceutical Company Ltd.).

Conditions

Healthy Volunteers

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (4)

• Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole

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

• AUC0_infobs: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value of the Last Quantifiable Concentration for Dexlansoprazole

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

• AUC0_infpred: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Predicted Value of the Last Quantifiable Concentration for Dexlansoprazole

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

Study Arms (4)

Part 1:Dexlansoprazole 30mg (TOB) + Dexlansoprazole 30mg (TPC)

EXPERIMENTAL

Dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (Regimen A \[test\]), orally, once, after a high fat/calorie breakfast on Day 1 of Period 1, followed by minimum of 5 day washout period, followed by dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (Regimen B \[reference\]), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2.

Drug: 30 mg dexlansoprazole capsules manufactured at TOB; Drug: 30 mg dexlansoprazole capsules manufactured at TPC

Part 1:Dexlansoprazole 30mg (TPC) + Dexlansoprazole 30mg (TOB)

EXPERIMENTAL

Dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (Regimen B \[reference\]), orally, once, after a high fat/calorie breakfast on Day 1 of Period 1, followed by minimum of 5 day washout period, followed by dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (Regimen A \[test\]), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2.

Drug: 30 mg dexlansoprazole capsules manufactured at TOB; Drug: 30 mg dexlansoprazole capsules manufactured at TPC

Part 2:Dexlansoprazole 60mg (TOB) + Dexlansoprazole 60mg (TPC)

EXPERIMENTAL

Dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (Regimen C \[test\]), orally, once, after a high fat/calorie breakfast on Day 1 of Period 1, followed by minimum of 5 day washout period, followed by dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (Regimen D \[reference\]), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2.

Drug: 60 mg dexlansoprazole capsules manufactured at TOB; Drug: 60 mg dexlansoprazole capsules manufactured at TPC

Part 2:Dexlansoprazole 60mg (TPC) + Dexlansoprazole 60mg (TOB)

EXPERIMENTAL

Dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (Regimen D \[reference\]), orally, once, after a high fat/calorie breakfast on Day 1 of Period 1, followed by minimum of 5 day washout period, followed by dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (Regimen C \[test\]), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2.

Drug: 60 mg dexlansoprazole capsules manufactured at TOB; Drug: 60 mg dexlansoprazole capsules manufactured at TPC

Interventions

30 mg dexlansoprazole capsules manufactured at TOB DRUG

Dexlansoprazole delayed-release capsules.

Part 1:Dexlansoprazole 30mg (TOB) + Dexlansoprazole 30mg (TPC); Part 1:Dexlansoprazole 30mg (TPC) + Dexlansoprazole 30mg (TOB)

30 mg dexlansoprazole capsules manufactured at TPC DRUG

Dexlansoprazole delayed-release capsules.

Part 1:Dexlansoprazole 30mg (TOB) + Dexlansoprazole 30mg (TPC); Part 1:Dexlansoprazole 30mg (TPC) + Dexlansoprazole 30mg (TOB)

60 mg dexlansoprazole capsules manufactured at TOB DRUG

Dexlansoprazole delayed-release capsules.

Part 2:Dexlansoprazole 60mg (TOB) + Dexlansoprazole 60mg (TPC); Part 2:Dexlansoprazole 60mg (TPC) + Dexlansoprazole 60mg (TOB)

60 mg dexlansoprazole capsules manufactured at TPC DRUG

Dexlansoprazole delayed-release capsules.

Part 2:Dexlansoprazole 60mg (TOB) + Dexlansoprazole 60mg (TPC); Part 2:Dexlansoprazole 60mg (TPC) + Dexlansoprazole 60mg (TOB)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Has a body mass index (BMI) from 18 to 30 kilogram per square meter (kg/m\^2), at Screening.
• Is willing and able to consume the high-fat/high-calorie breakfast administered during the study.

You may not qualify if:

• Has a history of drug abuse (defined as any illicit drug use) or drug addiction in the 12 months prior to Screening or a history of alcohol abuse (defined as regular consumption exceeding 21 units per week \[1 unit equal (=) 12 ounces (oz) beer, 1.5 oz hard liquor, or 5 oz wine\]) within 1 year prior to the Screening Visit, or is unwilling to agree to abstain from alcohol and drugs throughout the study.
• Has a positive test result for drugs of abuse (defined as any illicit drug use) or alcohol at Screening or Check-in (Day -1 of Period 1).
• Has received any known hepatic or renal clearance altering agents (example, erythromycin, cimetidine, barbiturates, phenothiazines, fluvoxamine, etc) for a period of 28 days prior to Day 1 of Period 1.
• Has donated blood products (such as plasma) within 30 days or has donated whole blood or lost 450 milliliter (mL) or more of his or her blood volume, or had a transfusion of any blood product within 56 days prior to Day 1 of Period 1.
• With the exception of acetaminophen, the subject has taken any excluded medication, supplements, or food products or beverages containing grapefruit or grapefruit juice, star fruit or star fruit juice, Seville-type (sour) oranges and marmalade, apple, orange, or pineapple juice, vegetables from the mustard green family (example, kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, mustard), and charbroiled meats. Hormonal contraception and hormone replacement therapy are allowed, as long as the subject has been on a stable dose for a minimum of 90 days prior to Day 1 of Period 1.
• Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch nicotine gum, e-cigarettes) within 28 days prior to Check-in (Day -1 of Period 1), or has a positive cotinine test at Screening or Check-in (Day -1 of Period 1), or is unwilling to abstain from these products for the duration of the study.
• Has received dexlansoprazole or lansoprazole in a previous clinical study or as a therapeutic agent within 6 months of screening.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Interventions

Dexlansoprazole

Intervention Hierarchy (Ancestors)

Lansoprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic 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: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 11, 2019
• Study Start: January 10, 2019
• Primary Completion: February 25, 2019
• Study Completion: April 9, 2019
• Last Updated: March 19, 2020
• Results First Posted: March 19, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)