BioavailabilityPhase 1NCT02064907
Bioavailability, Safety, and Pharmacodynamics of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets in Healthy Participants
A Phase 1 study testing Dexlansoprazole Delayed Release Orally Disintegrating Tablets and Dexlansoprazole Delayed Release Capsules in people with Bioavailability, run by Takeda at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability
- What is being tested?
- Dexlansoprazole Delayed Release Orally Disintegrating Tablets and Dexlansoprazole Delayed Release Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Apr 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- 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.
- 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.
- Has poor peripheral venous access.
- 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.
- 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.
- 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.
- Has a positive breath test result for H pylori at Screening.
- Has a history of a disorder in metabolizing phenylalanine (phenylketonuria).
- Cannot tolerate placement of the pH probe.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Open-Label, Single Center, Multiple-Dose, Two-Period, Crossover Study to Assess the Bioavailability, Safety, and Pharmacodynamics of Two 30 mg Dexlansoprazole Delayed-Release Orally Disintegrating Tablets Administered on the Tongue Relative to Oral Administration of One 60 mg Dexlansoprazole Delayed-Release Capsule in Healthy Subjects
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.
Read the detailed description
The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being tested to see if two different forms of the medication react the same way in the human body. This study will look at biological samples from people who take an orally disintegrating tablet of dexlansoprazole compared to a swallowed capsule of dexlansoprazole.
The study will enroll approximately 52 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups. Both treatment groups will receive both forms of dexlansoprazole at different time periods:
- Two dexlansoprazole 30 mg orally disintegrating tablets for 5 days
- One dexlansoprazole 60 mg capsule for 5 days.
All participants will be asked to take two tablets or one capsule at the same time each day throughout each treatment period of the study.
This single-centre trial will be conducted in the United States. Participants will make 3 visits to the clinic including two 6-day periods of confinement to the clinic, and will be contacted by telephone 5 to 10 days after last dose of study drug for a follow-up assessment.
The overall time to participate in this study is up to 57 days.
- Conditions
- Bioavailability
- Being tested
- Dexlansoprazole Delayed Release Orally Disintegrating Tablets, Dexlansoprazole Delayed Release Capsules
- Keywords
- Drug therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexlansoprazole Delayed Release Orally Disintegrating TabletsDrug
Dexlansoprazole delayed-release, orally disintegrating (OD) tablets
Dexlansoprazole Delayed Release CapsulesDrug
Also called Dexilant
Dexlansoprazole delayed-release capsules
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Dexlansoprazole Delayed Release Orally Disintegrating Tablets; Drug: Dexlansoprazole Delayed Release Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Day 5 predose and up to 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BioavailabilityStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02064907
- Sponsor's protocol ID
- TAK-390MR(OD)_104
- Other IDs
- U1111-1151-7112
- Status last verified
- Mar 2015
- First submitted
- 14 Feb 2014
- Last updated
- 14 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-Label, Single Center, Multiple-Dose, Two-Period, Crossover Study to Assess the Bioavailability, Safety, and Pharmacodynamics of Two 30 mg Dexlansoprazole Delayed-Release Orally Disintegrating Tablets Administered on the Tongue Relative to Oral Administration of One 60 mg Dexlansoprazole Delayed-Release Capsule in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02064907
- Acronym / sponsor ID
- TAK-390MR(OD)_104
- Conditions
- Bioavailability
- Keywords
- Drug therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 17 Feb 2014 (estimated)
- Results
- Posted 14 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being tested to see if two different forms of the medication react the same way in the human body. This study will look at biological samples from people who take an orally disintegrating tablet of dexlansoprazole compared to a swallowed capsule of dexlansoprazole.
The study will enroll approximately 52 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups. Both treatment groups will receive both forms of dexlansoprazole at different time periods:
- Two dexlansoprazole 30 mg orally disintegrating tablets for 5 days
- One dexlansoprazole 60 mg capsule for 5 days.
All participants will be asked to take two tablets or one capsule at the same time each day throughout each treatment period of the study.
This single-centre trial will be conducted in the United States. Participants will make 3 visits to the clinic including two 6-day periods of confinement to the clinic, and will be contacted by telephone 5 to 10 days after last dose of study drug for a follow-up assessment.
The overall time to participate in this study is up to 57 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexlansoprazole OD Tablets + Dexlansoprazole Capsules | Experimental | Drug: Dexlansoprazole Delayed Release Orally Disintegrating Tablets, Drug: Dexlansoprazole Delayed Release CapsulesTwo 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. |
| Dexlansoprazole Capsules + Dexlansoprazole OD | Experimental | Drug: Dexlansoprazole Delayed Release Orally Disintegrating Tablets, Drug: Dexlansoprazole Delayed Release CapsulesDexlansoprazole 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (24 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexlansoprazole Delayed Release Orally Disintegrating TabletsDexlansoprazole delayed-release, orally disintegrating (OD) tablets | Drug | Dexlansoprazole Capsules + Dexlansoprazole OD, Dexlansoprazole OD Tablets + Dexlansoprazole Capsules |
| Dexlansoprazole Delayed Release CapsulesAlso: DexilantDexlansoprazole delayed-release capsules | Drug | Dexlansoprazole Capsules + Dexlansoprazole OD, Dexlansoprazole OD Tablets + Dexlansoprazole Capsules |
Primary outcome
Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole on Day 1.
Time frame: Day 1 predose and up to 24 hours post-dose
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole on Day 5
Time frame: Day 5 predose and up to 24 hours post-dose
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration on Day 1
Time frame: Day 1 predose and up to 24 hours post-dose
AUC(0-tlqc) is a measure of total plasma exposure to a drug from time 0 to time of the last quantifiable concentration.
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration on Day 5
Time frame: Day 5 predose and up to 24 hours post-dose
AUC(0-tlqc) is a measure of total plasma exposure to a drug from time 0 to time of the last quantifiable concentration.
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity on Day 1
Time frame: Day 1 predose and up to 24 hours post-dose
AUC(0-inf) is a measure of the area under the plasma concentration-time curve from time 0 extrapolated to infinity.
AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval on Day 5
Time frame: Day 5 predose and up to 24 hours post-dose
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director Clinical Science study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dexlansoprazole Delayed Release Orally Disintegrating Tablets and Dexlansoprazole Delayed Release Capsules in people with Bioavailability, run by Takeda at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole on Day 1. (time frame: Day 1 predose and up to 24 hours post-dose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2015.