A Phase 1 interventional study of Tolvaptan and Tolvaptan in Healthy, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-12-07.
Sponsored by University of North Carolina, Chapel Hill · Phase 1, Interventional, and Treatment
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.
This study is an open 2-treatment, 2-period, 2-sequence crossover study to compare the relative bioavailability of tolvaptan tablets to tolvaptan NG in 28 healthy adults. The study will be conducted at the University of North Carolina (UNC) Hospital in the Clinical Translational Research Center (CTRC). The study will consist of three phases (screening and two drug administration visits). 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 (NG) tube, or the reverse sequence. Because enrollment will be staggered and males and females enrolled, the randomization will be blocked (groups of 4) to minimize imbalance in assignment to the two sequences during the enrollment period, and will be used in a bidirectional fashion to balance gender, with males entering with the lowest subject numbers (#1, #2, etc.), and females with the highest subject numbers (#32, #31, etc.) in the randomization schedule. The biomedical informatics core will generate the randomization schedule. During each inpatient phase, pharmacokinetic parameters will be monitored for 36 hours. Subjects will remain in the CTRC for 24 hours after each drug administration to allow for adequate pharmacokinetic sampling. Subjects will return to the clinic on study days 2 and 9 of the study schedule for 30 and 36 hour blood samples. Subjects will then undergo a one-week washout period and then will be crossed over to the alternative mode of administration. Subjects will be discharged from the study after vital signs are checked on study days 2 and 9 of the study schedule at 36 hours, assuming the subject is hemodynamically stable.
University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Exclusion Criteria:
Drug: Tolvaptan
Drug: Tolvaptan
Tolvaptan 15 mg administered once orally as an intact tablet.
Also known as: Samsca
Tolvaptan 15 mg administered once via nasogastric tube.
Also known as: Samsca
Area under the plasma drug concentration-time curve from time 0 to infinity (AUC)
Time frame: 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
Maximum plasma concentration (Cmax)
Time frame: PK samples: from pre-dose to 36 hours
Time to maximal concentration (Tmax)
Time frame: PK samples: pre-dose to 36 hours
This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.
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University of North Carolina, Chapel Hill