Study to Assess Food Effect on Sativex Bioavailability

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier:
NCT01322464
First received: March 23, 2011
Last updated: June 13, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Food Effect
Drug: Sativex
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: 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

Further study details as provided by GW Pharmaceuticals Ltd.:

Primary Outcome Measures:
  • Primary PK Endpoints [ Designated as safety issue: No ]
    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:
  • Secondary PK measures [ Designated as safety issue: No ]
    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 [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: January 2008
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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 fed state on Day 1. 4 sprays Sativex in fasted state on Day 4. 4 sprays Sativex daily in fasted state Days 5-13.
Experimental: Group 2
2 sprays Sativex daily in fasted state.
Drug: Sativex
2 sprays Sativex daily in fasted state Days 4-13.
Experimental: Group 3
8 sprays sativex daily in fasted state.
Drug: Sativex
8 sprays Sativex daily in fasted state Days 4-13.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01322464

Locations
United Kingdom
Guy's Drug Research Unit, Quintiles Ltd.
London, United Kingdom, SE1 1YR
Sponsors and Collaborators
GW Pharmaceuticals Ltd.
  More Information

Publications:
Responsible Party: GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT01322464     History of Changes
Other Study ID Numbers: GWCP0601
Study First Received: March 23, 2011
Last Updated: June 13, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by GW Pharmaceuticals Ltd.:
Sativex
bio-availability
cannabinoid
pharmacokinetics

ClinicalTrials.gov processed this record on July 29, 2014