Bioavailability, Safety, and Pharmacodynamics of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets in Healthy Participants

NCT02064907 | Completed Phase 1 Results

• 2 other identifiers: TAK-390MR(OD)_104U1111-1151-7112
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the pharmacokinetics (PK) and Pharmacodynamics (PD) of dexlansoprazole delayed-release orally disintegrating (OD) tablets administered on the tongue and swallowed without water.

Conditions

Bioavailability

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (6)

• Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole on Day 1.

  Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.

  Day 1 predose and up to 24 hours post-dose

• Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole on Day 5

  Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.

  Day 5 predose and up to 24 hours post-dose

• AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration on Day 1

  AUC(0-tlqc) is a measure of total plasma exposure to a drug from time 0 to time of the last quantifiable concentration.

  Day 1 predose and up to 24 hours post-dose

• AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration on Day 5

  AUC(0-tlqc) is a measure of total plasma exposure to a drug from time 0 to time of the last quantifiable concentration.

  Day 5 predose and up to 24 hours post-dose

• AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity on Day 1

  AUC(0-inf) is a measure of the area under the plasma concentration-time curve from time 0 extrapolated to infinity.

  Day 1 predose and up to 24 hours post-dose

• AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval on Day 5

  AUC(0-tau) is a measure of the area under the plasma concentration-time curve from time 0 to time tau over a dosing interval, where tau is the length of the dosing interval (24 hours).

  Day 5 predose and up to 24 hours post-dose

Study Arms (2)

Dexlansoprazole OD Tablets + Dexlansoprazole Capsules

EXPERIMENTAL

Two Dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days in Period 1, followed by a 7 day washout period, followed by one dexlansoprazole 60 mg, capsule, orally, once daily for 5 days in Period 2.

Drug: Dexlansoprazole Delayed Release Orally Disintegrating Tablets; Drug: Dexlansoprazole Delayed Release Capsules

Dexlansoprazole Capsules + Dexlansoprazole OD

EXPERIMENTAL

Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days in Period 1, followed by a 7 day washout period, followed by two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days in Period 2.

Drug: Dexlansoprazole Delayed Release Orally Disintegrating Tablets; Drug: Dexlansoprazole Delayed Release Capsules

Interventions

Dexlansoprazole Delayed Release Orally Disintegrating Tablets DRUG

Dexlansoprazole delayed-release, orally disintegrating (OD) tablets

Dexlansoprazole Capsules + Dexlansoprazole OD; Dexlansoprazole OD Tablets + Dexlansoprazole Capsules

Dexlansoprazole Delayed Release Capsules DRUG

Dexlansoprazole delayed-release capsules

Also known as: Dexilant

Dexlansoprazole Capsules + Dexlansoprazole OD; Dexlansoprazole OD Tablets + Dexlansoprazole Capsules

Eligibility Criteria

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

You may qualify if:

• In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
• The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
• Is a healthy adult male or female participant by Check-in (Day -1 of Period 1).
• Is aged 18 to 55 years inclusive, by Screening and the first dosing day (Day 1 of Period 1).
• Weighs at least 50 kg and has a body mass index (BMI) between 18.0 and 30.0 kg/m\^2, inclusive at Screening.
• If a male participant is nonsterilized and sexually active with a female partner of childbearing potential, he agrees to use adequate contraception from signing of informed consent form throughout the duration of the study and for 30 days after the last dose of study drug.
• If a female participant of childbearing potential is sexually active with a nonsterilized male partner, she agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 30 days following the last dose of study drug. Female participants of childbearing potential must have a negative serum pregnancy test at Screening and Check-in (Day -1 of Period 1) and they must not be nursing.
• Is in good health as determined by a physician based on medical history, vital signs, electrocardiogram (ECG) and physical examination findings at Screening and Check-in (Day -1 of Period 1), as applicable.
• Has clinical chemistry, hematology, and complete urinalysis (fasted for at least 10 hours) at Screening and Check-in (Day -1 of Period 1) results within the reference range for the testing laboratory unless the out of range results are deemed not clinically significant by the investigator.

You may not qualify if:

• Has received any investigational compound within 30 days prior to Check-in (Day -1 of Period 1).
• Has ever received dexlansoprazole in a previous clinical study or has received dexlansoprazole or lansoprazole as a therapeutic agent within 28 days prior to Check-in (Day -1 of Period 1).
• Is an immediate family member, study site employee, or in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
• Has uncontrolled, clinically significant hematologic, neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine, psychiatric disorder or other abnormality (other than the disease being studied), which may impact the ability of the participant to participate or potentially confound the study results.
• Has a known hypersensitivity to any component of the formulation of dexlansoprazole delayed-release orally disintegrating (OD) tablets or participant has a known hypersensitivity to any component of the formulation of dexlansoprazole delayed-release capsules or other drug with the same mechanism of action (including esomeprazole, lansoprazole, omeprazole, pantoprazole, or rabeprazole).
• Consumed alcohol or drugs of abuse within 7 days prior to check-in (Day -1 of Period 1), has a positive test result for alcohol or drugs of abuse at Screening or Check-in (Day -1 of Period 1), or is unwilling to abstain from alcohol and drugs of abuse throughout the study.
• Has received any known hepatic or renal clearance altering agents (eg, erythromycin, cimetidine, barbiturates, phenothiazines, fluvoxamine, etc.) within 28 days prior to Day -1 of Period 1.
• Has had an acute, clinically significant illness within 30 days prior to Day 1 of Period 1.
• Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as alcohol consumption exceeding 14 units per week) within 1 year prior to the Screening Visit or is unwilling to agree to abstain from alcohol and drugs throughout the study.
• With the exception of acetaminophen, the participant has taken any excluded medication, supplements or food products.
• If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 30 days after participating in this study; or intending to donate ova during such time period.
• If male, the participant intends to impregnate others or donate sperm during the course of this study or for 30 days thereafter.
• Has consumed any products containing caffeine and/or xanthine within 72 hours prior to Check-in (Day -1 of Period 1) or is unwilling to abstain from these products for the duration of the study.
• Has current or recent (within 6 months of screening) gastrointestinal disease including esophageal reflux, frequent (more than once per week) occurrence of heartburn, history of malabsorption (ie, celiac disease, biliary atresia, cholestasis), peptic ulcer disease, or any surgical intervention \[eg, cholecystectomy, gastric bypass), which would be expected to influence the absorption of drugs.
• Has a history of cancer, except basal cell carcinoma of the skin that has not been in remission for at least 5 years prior to Day 1 of Period 1.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Unknown Facility

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: Takeda
• Organization: Takeda Study Registration Call Center

medicalinformation@tpna.com

+1-877-825-3327

Study Officials

• Medical Director Clinical Science

  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: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2014
• First Posted: February 17, 2014
• Study Start: February 1, 2014
• Primary Completion: March 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 14, 2015
• Results First Posted: April 14, 2015

Record last verified: 2015-03

Locations

US (1)