- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01261481
Bioavailability Study Comparing Tolvaptan Administered Via Nasogastric Tube to Tolvaptan Tablets Swallowed Intact
Comparison of the Relative Oral Bioavailability of Tolvaptan Administered Via Nasogastric Tube to Tolvaptan Tablets Swallowed Intact
The purpose of the study is to compare the relative bioavailability and pharmacokinetics of tolvaptan 15 mg tablets administered orally versus tolvaptan via nasogastric (NG) tube in healthy male and female subjects.
This study is an open 2-treatment, 2-period, 2-sequence crossover study to compare the relative bioavailability of tolvaptan tablets to tolvaptan given via nasogastric tube in 28 healthy adults. Subjects will be randomized to one of the two treatment sequences; either tolvaptan oral tablets swallowed intact followed by a tablet crushed and administered via nasogastric tube, or the reverse sequence. Serial pharmacokinetic samples will be collected following each tolvaptan administration and safety assessments will be performed. The relative bioavailability of tolvaptan administered via nasogastric tube will be compared to tolvaptan tablets swallowed intact.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- University of North Carolina Healthcare
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy - defined as being free from significant cardiac, pulmonary, gastrointestinal, hepatic, biliary, renal, hematological, neurological and psychiatric disease as determined by history, physical examination and clinical laboratory test results.
- Male or female between 18 and 40 years of age inclusive, at the time of signing the informed consent.
A female is eligible to enter and participate in this study if she is of:
i. Non-child bearing potential (i.e. postmenopausal, surgically sterile, bilateral tubal ligation, or oophorectomy); or
ii. Child bearing potential, has a negative serum pregnancy test at screening, a negative urine pregnancy test on each admission day, and certifies compliance with one of the following:
- Complete abstinence from intercourse from 2 weeks prior to administration of the study drug, throughout the study, and 3 days after completion or premature discontinuation from the study to account for elimination of the study drug; or
- Sterilization of monogamous male partner; or
- Oral contraceptives if the subject has been taking them continuously for at least three months prior to the study; or
- Any FDA approved non-hormonal intrauterine device (IUD); or
- Within 20% of ideal body weight based on the subject's height (inches) and weight (kg).
- Willing and able to give written informed consent prior to entering the study.
Exclusion Criteria:
- Participated in another study within 30 days of the study period.
- A serum sodium less than 135 mEq/L at screening or on study days 1 or 8 of the study schedule.
- A positive urine or serum pregnancy test, or are currently breast-feeding.
- A history of intestinal surgery or gastrointestinal disorder that may affect drug absorption.
- Any clinically significant abnormal result on the screening blood tests, ECG, or physical exam.
- Use of CYP3A4 inhibitors or inducers as medications, juices, or herbal supplements within 96 hours prior to the study period.
- Use of oral or intravenous antibiotics within 14 days of the study period.
- A current history of alcohol or drug abuse.
- Any alcohol consumption within 24 h prior to study days 1 and 8 of the study schedule.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Tolvaptan Intact Tablet Orally
|
Tolvaptan 15 mg administered once orally as an intact tablet.
Other Names:
Tolvaptan 15 mg administered once via nasogastric tube.
Other Names:
|
EXPERIMENTAL: Tolvaptan via Nasogastric Tube
|
Tolvaptan 15 mg administered once orally as an intact tablet.
Other Names:
Tolvaptan 15 mg administered once via nasogastric tube.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the plasma drug concentration-time curve from time 0 to infinity (AUC)
Time Frame: PK samples: from pre-dose to 36 hours
|
PK samples: from pre-dose to 36 hours
|
Area under the plasma drug concentration-time curve from time 0 to the last quantifiable point (AUC(0-t))
Time Frame: PK samples: from pre-dose to 36 hours
|
PK samples: from pre-dose to 36 hours
|
Maximum plasma concentration (Cmax)
Time Frame: PK samples: from pre-dose to 36 hours
|
PK samples: from pre-dose to 36 hours
|
Time to maximal concentration (Tmax)
Time Frame: PK samples: pre-dose to 36 hours
|
PK samples: pre-dose to 36 hours
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: J. Herbert Patterson, PharmD, University of North Caronlina - Eshelman School of Pharmacy
- Study Director: Elizabeth B McNeely, PharmD, University of North Caronlina - Eshelman School of Pharmacy
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-1865
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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