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NCT01887301 · ClinicalTrials.gov registry record · Phase 1
Assessment of the Single Dose Pharmacokinetics and Tolerability of Sativex in Patients With Impaired Hepatic Function and Healthy Patients
A Phase 1 study of Hepatic Impairment, sponsored by Jazz Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 2
- Study locations
NCT01887301: Completed Phase 1 study of Hepatic Impairment, sponsored by Jazz Pharmaceuticals.
NCT01887301 is a Phase 1 study of Hepatic Impairment that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 32 participants, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (11% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01887301, a Phase 1 study of Hepatic Impairment, has completed, sponsored by Jazz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 2
- Study locations
Study Summary
A Phase I open-label study to evaluate the pharmacokinetics (what the body does to a drug), safety and tolerability of a single dose of Sativex (containing 10.8 mg tetrahydrocannabinol \[THC\] and 10 mg cannabidiol \[CBD\]) in healthy patients and those with hepatic (liver) function impairment.
Primary Outcome
All blood samples will be taken by either direct venipuncture or an indwelling cannula inserted in a forearm vein. For pharmacokinetic (PK) assessments, blood will be drawn from each patient into a five mL lithium-heparinised tube at the following intervals (±five min): Pre-dose (0),0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 11, 24, 36 and 48 hours post dose. Collected blood samples will be used to confirm correct dosing, and to provide information about the plasma concentrations of unb
Conditions Studied
Interventions
- DRUG Sativex
Study Locations (2)
California
- Anaheim Clinical Trials, LLC - Anaheim
Florida
- Clinical Pharmacology of Miami, Inc. - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2013-07 |
| Est. Completion | 2014-05 |
| Phase | Phase 1 |
What the finished NCT01887301 record still lists
NCT01887301 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (11% lower).
The record links to 1 condition, with Hepatic Impairment appearing as the primary indexed condition, and to 1 intervention - of which Sativex is the first listed.
NCT01887301 reports a single indexed study location in California, Florida.
Frequently Asked Questions
What is clinical trial NCT01887301 about?
NCT01887301 is a clinical study titled "Assessment of the Single Dose Pharmacokinetics and Tolerability of Sativex in Patients With Impaired Hepatic Function and Healthy Patients". A Phase I open-label study to evaluate the pharmacokinetics (what the body does to a drug), safety and tolerability of a single dose of Sativex (containing 10.8 mg tetrahydrocannabinol \[THC\] and 10 mg cannabidiol \[CBD\]) in healthy patients and those with hepatic (liver) function impairment.
What is the current status of trial NCT01887301?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2013-07. Estimated completion is 2014-05.
What conditions does trial NCT01887301 study?
This clinical trial studies the following conditions: Hepatic Impairment.
What interventions are being tested in trial NCT01887301?
The interventions under investigation include: Sativex (DRUG).
Who is sponsoring clinical trial NCT01887301?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01887301 being conducted?
This trial has 2 study locations across California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hepatic Impairment
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01887301's enrollment target sits among peer trials
32 13th of 48 higher than 30 of 48 other Hepatic Impairment trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatic Impairment trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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