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

March 23, 2011
June 13, 2013
January 2008
February 2008   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01322464 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study to Assess Food Effect on Sativex Bioavailability
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Food Effect
  • 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 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.

    Intervention: Drug: Sativex
  • 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.

    Intervention: Drug: Sativex
  • Experimental: Group 2
    2 sprays Sativex daily in fasted state.
    Intervention: Drug: Sativex
  • Experimental: Group 3
    8 sprays sativex daily in fasted state.
    Intervention: Drug: Sativex

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
February 2008
February 2008   (final data collection date for primary outcome measure)

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).
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01322464
GWCP0601
No
GW Pharmaceuticals Ltd.
GW Pharmaceuticals Ltd.
Not Provided
Not Provided
GW Pharmaceuticals Ltd.
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP