Bioavailability, Safety, and Pharmacodynamics of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets in Healthy Participants
Condition: Bioavailability
Intervention: Dexlansoprazole Delayed Release Orally Disintegrating Tablets; Dexlansoprazole Delayed Release Capsules
Intervention description: Dexlansoprazole delayed-release, orally disintegrating (OD) tablets; Dexlansoprazole delayed-release capsules
Intervention MeSH terms: Dexlansoprazole; Lansoprazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug therapy

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. In the opinion of the investigator, the participant is capable of understanding and
             complying with protocol requirements.

          2. 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.

          3. Is a healthy adult male or female participant by Check-in (Day -1 of Period 1).

          4. Is aged 18 to 55 years inclusive, by Screening and the first dosing day (Day 1 of
             Period 1).

          5. Weighs at least 50 kg and has a body mass index (BMI) between 18.0 and 30.0 kg/m^2,
             inclusive at Screening.

          6. 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.

          7. 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.

          8. 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.

          9. 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.

        Exclusion Criteria:

          1. Has received any investigational compound within 30 days prior to Check-in (Day -1 of
             Period 1).

          2. 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).

          3. 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.

          4. 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.

          5. 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).

          6. 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.

          7. 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.

          8. Has had an acute, clinically significant illness within 30 days prior to Day 1 of
             Period 1.

          9. 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.

         10. With the exception of acetaminophen, the participant has taken any excluded
             medication, supplements or food products.

         11. 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.

         12. If male, the participant intends to impregnate others or donate sperm during the
             course of this study or for 30 days thereafter.

         13. 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.

         14. 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.

         15. 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.

         16. Has a positive test result for hepatitis B surface antigen (HBsAg), or hepatitis C
             antibody (HCV), at Screening or a known history of human immunodeficiency virus
             infection.

         17. Used any nicotine-containing products (including but not limited to cigarettes, pipe,
             cigar, chewing tobacco, nicotine patch, or nicotine gum) 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.

         18. Has poor peripheral venous access.

         19. Has donated or lost 450 mL or more of his or her blood volume (including
             plasmapheresis), or had a transfusion of any blood product within 56 days prior to Day
             1 of Period 1.

         20. Has a Screening or Check-in (Day -1 of Period 1) abnormal (clinically significant)
             ECG. Entry of any participant with an abnormal (not clinically significant) ECG must
             be approved, and documented by signature by the principal investigator or medically
             qualified sub-investigator.

         21. Has abnormal Screening or Day -1 laboratory values that suggest a clinically
             significant underlying disease or participant with the following lab abnormalities:
             creatinine >1.5 mg/dL, alanine aminotransferase (ALT) and/or aspartate
             aminotransferase (AST) >2.5× the upper limit of normal (ULN), or total bilirubin >2.0
             mg/dL.

         22. Has a positive breath test result for H pylori at Screening.

         23. Has a history of a disorder in metabolizing phenylalanine (phenylketonuria).

         24. Cannot tolerate placement of the pH probe.