Study to Assess Food Effect on Sativex Bioavailability

April 7, 2023 updated by: Jazz Pharmaceuticals

A Phase I Study to Assess the Effect of Food on the Single-Dose Bioavailability of Sativex, and to Compare the Single and Multiple Dose Pharmacokinetics of Sativex at Three Dose Levels

Study to assess effect of food on the bioavailability of a single dose of Sativex and to measure its' pharmacokinetics after a single and multiple doses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was an open-label, randomised, ascending dose, 2-way crossover food-effect study incorporating a parallel single and multiple dose components in healthy subjects.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE1 1YR
        • Guy's Drug Research Unit, Quintiles Ltd.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy males between 18 and 45 years of age (inclusive).
  • Body mass index to be between 18 to 30 kg/m2 (inclusive) as calculated by weight(Kg)/height(m2).
  • Subjects were to have no clinically significant abnormal findings on physical examination, ECG, medical history, or clinical laboratory results during screening.
  • Subjects were to, in the opinion of the investigator, have no clinically significant abnormal findings of renal and hepatic function as determined by serum creatinine, total bilirubin, and transaminase levels.
  • Subjects were to be non-users of tobacco products (minimum of 6 months prior to the start of the study).
  • Subjects were to have a negative screen for HIV I and II, HBsAg, and antibody to Hepatitis C virus.
  • Subjects were to have a negative urine screen for alcohol, drugs of abuse (screening only), and cotinine.
  • Subjects were to use an appropriate barrier method of contraception (condom and spermicide) in addition to having their female partner use another form of barrier contraception (e.g.female condom or occlusive cap with spermicide) during the study and for 3 months following administration of the study drug.
  • Subjects were able to comply with the protocol and the restrictions and assessments therein.
  • Subjects were to give voluntary written informed consent to participate in the trial.

Exclusion Criteria:

  • Subjects were not to have a history or presence of significant cardiovascular, pulmonary, hepatic, renal, haematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
  • Subjects were not to have any history or presence or family history of schizophrenia, other psychotic illness, severe personality disorder, depression, or other significant psychiatric disorder.
  • Subjects were not to have a postural drop of 20 mmHg or more in systolic blood pressure at screening.
  • Subjects were not to have participated in a previous clinical trial within 90 days prior to study initiation.
  • Subjects were not to have donated plasma within 90 days prior to study initiation.
  • Subjects were not to have donated blood within 90 days prior to study initiation.
  • Subjects were not to have had an abnormal diet or substantial changes in eating habits within 30 days prior to study initiation.
  • Subjects were not to have had treatment with any known enzyme-altering agents (barbiturates, phenothiazines, cimetidine etc.) within 30 days prior to or during the study.
  • Subjects were to have no history of known hypersensitivity or idiosyncratic reaction to the study drug or related compounds.
  • Subjects were not to use any prescription medication within 14 days prior to or during the study.
  • Subjects were not to use any over-the-counter medication within 7 days prior to or during the study.
  • Subjects were not to have a history of alcohol or drug abuse within 2 years prior to the study (subjects with a history of previous use of cannabis were not excluded unless they had used cannabis or cannabinoid based medicine within 30 days prior to study drug administration or were unwilling to abstain for the duration of the study).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1 Fasted-Fed

4 sprays Sativex in fasted state, followed by wash-out followed by 4 sprays Sativex in fed state.

Followed by 4 sprays daily in fasted state.
Drug: Sativex
4 sprays Sativex in fasted state on Day 1. 4 sprays Sativex in fed state on Day 4. 4 sprays Sativex daily in fasted state Days 5-13.
Drug: Sativex
4 sprays Sativex in fed state on Day 1. 4 sprays Sativex in fasted state on Day 4. 4 sprays Sativex daily in fasted state Days 5-13.
Drug: Sativex
2 sprays Sativex daily in fasted state Days 4-13.
Drug: Sativex
8 sprays Sativex daily in fasted state Days 4-13.
Experimental: Group 1 Fed-Fasted

4 sprays sativex in fed state followed by wash-out followed by 4 sprays Sativex in fasted state.

Followed by 4 sprays daily in fasted state.
Drug: Sativex
4 sprays Sativex in fasted state on Day 1. 4 sprays Sativex in fed state on Day 4. 4 sprays Sativex daily in fasted state Days 5-13.
Drug: Sativex
4 sprays Sativex in fed state on Day 1. 4 sprays Sativex in fasted state on Day 4. 4 sprays Sativex daily in fasted state Days 5-13.
Drug: Sativex
2 sprays Sativex daily in fasted state Days 4-13.
Drug: Sativex
8 sprays Sativex daily in fasted state Days 4-13.
Experimental: Group 2
2 sprays Sativex daily in fasted state.
Drug: Sativex
4 sprays Sativex in fasted state on Day 1. 4 sprays Sativex in fed state on Day 4. 4 sprays Sativex daily in fasted state Days 5-13.
Drug: Sativex
4 sprays Sativex in fed state on Day 1. 4 sprays Sativex in fasted state on Day 4. 4 sprays Sativex daily in fasted state Days 5-13.
Drug: Sativex
2 sprays Sativex daily in fasted state Days 4-13.
Drug: Sativex
8 sprays Sativex daily in fasted state Days 4-13.
Experimental: Group 3
8 sprays sativex daily in fasted state.
Drug: Sativex
4 sprays Sativex in fasted state on Day 1. 4 sprays Sativex in fed state on Day 4. 4 sprays Sativex daily in fasted state Days 5-13.
Drug: Sativex
4 sprays Sativex in fed state on Day 1. 4 sprays Sativex in fasted state on Day 4. 4 sprays Sativex daily in fasted state Days 5-13.
Drug: Sativex
2 sprays Sativex daily in fasted state Days 4-13.
Drug: Sativex
8 sprays Sativex daily in fasted state Days 4-13.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Primary PK Endpoints
Cmax, AUC(0-inf), T-half and CL/F: under fasting conditions (Group 1, Day 1 and 4 fasted data) and under fed conditions (Group 1 Day 1 and 4 fed data)

Secondary Outcome Measures

Outcome Measure
Measure Description
Secondary PK measures
Cmax, Tmax, AUC(0-t), t-half, CL/F, Varea/F from Day 4 (Groups 2 and 3) and from fasted subjects on days 1 and 4 (Group 1) Cmax, Cmin, Tmax, AUC(0-t), Flux from Day 12 data (all groups)
Safety and tolerability of Sativex

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jazz Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

March 23, 2011

First Submitted That Met QC Criteria

March 23, 2011

First Posted (Estimate)

March 24, 2011

Study Record Updates

Last Update Posted (Actual)

April 10, 2023

Last Update Submitted That Met QC Criteria

April 7, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GWCP0601

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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