Food EffectPhase 1NCT01322464
Study to Assess Food Effect on Sativex Bioavailability
A Phase 1 study testing Sativex in people with Food Effect, run by Jazz Pharmaceuticals at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Food Effect
- What is being tested?
- Sativex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2008to Feb 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guy's Drug Research Unit, Quintiles Ltd.
London, SE1 1YR
About this study
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
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.
Read the 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.
- Conditions
- Food Effect
- Being tested
- Sativex
- Keywords
- Sativex, bio-availability, cannabinoid, pharmacokinetics
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SativexDrug
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.
SativexDrug
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.
SativexDrug
2 sprays Sativex daily in fasted state Days 4-13.
SativexDrug
8 sprays Sativex daily in fasted state Days 4-13.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Fasted-Fed | Experimental | 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. Receives: Drug: Sativex |
| Group 1 Fed-Fasted | Experimental | 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. Receives: Drug: Sativex |
| Group 2 | Experimental | 2 sprays Sativex daily in fasted state. Receives: Drug: Sativex |
| Group 3 | Experimental | 8 sprays sativex daily in fasted state. Receives: Drug: Sativex |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (2)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2011 (estimated)
- Study startJan 2008
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Food EffectStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322464
- Sponsor's protocol ID
- GWCP0601
- Status last verified
- Apr 2023
- First submitted
- 23 Mar 2011
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Stott CG, White L, Wright S, Wilbraham D, Guy GW. A phase I study to assess the effect of food on the single dose bioavailability of the THC/CBD oromucosal spray. Eur J Clin Pharmacol. 2013 Apr;69(4):825-34. doi: 10.1007/s00228-012-1393-4. Epub 2012 Oct 4.
PubMed 23052407Stott CG, White L, Wright S, Wilbraham D, Guy GW. A phase I study to assess the single and multiple dose pharmacokinetics of THC/CBD oromucosal spray. Eur J Clin Pharmacol. 2013 May;69(5):1135-47. doi: 10.1007/s00228-012-1441-0. Epub 2012 Nov 22.
PubMed 23179176
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01322464
- Acronym / sponsor ID
- GWCP0601
- Conditions
- Food Effect
- Keywords
- Sativex, bio-availability, cannabinoid, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 24 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 Fasted-Fed | Experimental | Drug: Sativex4 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. |
| Group 1 Fed-Fasted | Experimental | Drug: Sativex4 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. |
| Group 2 | Experimental | Drug: Sativex2 sprays Sativex daily in fasted state. |
| Group 3 | Experimental | Drug: Sativex8 sprays sativex daily in fasted state. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sativex4 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 | Group 1 Fasted-Fed |
| Sativex4 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 | Group 1 Fed-Fasted |
| Sativex2 sprays Sativex daily in fasted state Days 4-13. | Drug | Group 2 |
| Sativex8 sprays Sativex daily in fasted state Days 4-13. | Drug | Group 3 |
Primary outcome
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)
2 secondary outcomes
Secondary PK measures
Safety and tolerability of Sativex
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- Results publication: PubMed 23052407Stott CG, White L, Wright S, Wilbraham D, Guy GW. A phase I study to assess the effect of food on the single dose bioavailability of the THC/CBD oromucosal spray. Eur J Clin Pharmacol. 2013 Apr;69(4):825-34. doi: 10.1007/s00228-012-1393-4. Epub 2012 Oct 4.
- Results publication: PubMed 23179176Stott CG, White L, Wright S, Wilbraham D, Guy GW. A phase I study to assess the single and multiple dose pharmacokinetics of THC/CBD oromucosal spray. Eur J Clin Pharmacol. 2013 May;69(5):1135-47. doi: 10.1007/s00228-012-1441-0. Epub 2012 Nov 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sativex in people with Food Effect, run by Jazz Pharmaceuticals at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary PK Endpoints. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01322464, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2023.