Bipolar DisorderPhase 1NCT00483535
Oral Contraceptive Interaction Study for GW273225
A Phase 1 study testing GW273225 and COC in people with Bipolar Disorder, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
GW273225 is in development for epilepsy and bipolar disorder and can affect women of child bearing potential. A clear understanding of the potential interaction between oral contraceptives and GW273225 is therefore important for clinical investigation of GW273225 in a large number of patients. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- GW273225 and COC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Mar 2007to 16 Nov 2007
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female subjects aged between 18 and 45 years, inclusive.
- Body weight >50 kg and Body Mass Index (BMI) within the range 19-29.9 kg/m2 inclusive.
- Female subjects of child bearing potential will be eligible to participate if they are established on a Microgynon 30 or Ovranette for the previous month
- If taking a similar ethinyl oestradiol dose (30 or 35 mcg) combined with a progestogen at fixed dose for 21 days then willing to switch to Microgynon 30
- Subjects will use additional contraception as described in the protocol. One of the methods listed in the protocol is acceptable in conjunction with COC as the method of contraception if there is indisputable data that it is >99% effective, otherwise it should be used with a barrier method (condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository).
- Subjects must smoke ≤ 10 cigarettes per day.
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- No abnormality on relevant clinical examination. A subject with a clinical abnormality may be included only if the Investigator in consultation with the GSK Medical Monitor considers that the abnormality will not introduce additional risk factors and will not interfere with the study procedures.
- No abnormality on relevant clinical chemistry or haematology examination at the pre-study medical examination. Subjects with laboratory parameters outside the reference range for this age group will only be included if the Investigator in consultation with the GSK Medical Monitor considers that such findings will not introduce additional risk factors.
- A 12-lead ECG and vital signs at the pre-study medical examination, which are normal. (including QTc which is <450msec)
- The subject has signed and dated written informed consent prior to admission to the study
- The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
Who cannot join
- History or evidence of drug or alcohol abuse within six months of study start.
- Weekly alcohol intake of more than 14 units or an average daily intake of greater than 2 units.
- Female subject pregnant (positive serum human chorionic gonadotrophin (hCG) test at screening) or lactating. HIV, Chronic hepatitis B and C, as evidenced by positive Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody
- Subject has received prescribed or non-prescribed medication (including vitamins and herbal remedies) within 14 days prior to day 1 which in the opinion of the investigator, could have interfered with the study procedures or compromised safety.
- History of gastro-intestinal, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- History of thrombotic events or presence of significant risk factors for thrombosis.
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- Supine Blood Pressure greater than or equal to 140/90.
- Progestogen- releasing IUD contraceptive.
- Participation in a trial with any drug within 84 days before the start of the study.
- Donation of more than 1500 mL blood in the previous 12 months.
- History or presence of any condition contra-indicated to combined oral contraceptive.
- Any subject where the potential side effects of GW273225 could affect their professional occupation, e.g. operating machinery, driving.
- Any subjects who cannot refrain from driving for the duration of administration of GW273225 and for 3 days afterwards.
- History of clinically relevant skin rashes that, in the opinion of the investigator, might interfere with the conduct of the study.
- Subject has current or past history of seizure disorder or brain injury (traumatic or disease-related), or any condition which, in the opinion of the investigator, predisposes to seizure; subject treated with other medications or treatment regimens that lower seizure threshold; subject undergoing abrupt discontinuation of alcohol or sedatives (including benzodiazepines).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
GSK Investigational Site
Cambridge, Cambridgeshire, CB3 7TR
About this study
Official title: An Open, Repeat Dose Study to Investigate the Effect of Co-administration of the Combined Oral Contraceptive Pill (COC) and GW273225 on the Pharmacokinetics of the COC and to Investigate the Effects of the COC on the Pharmacokinetics of GW273225 in Healthy Female Subjects
GW273225 is in development for epilepsy and bipolar disorder and can affect women of child bearing potential. A clear understanding of the potential interaction between oral contraceptives and GW273225 is therefore important for clinical investigation of GW273225 in a large number of patients. This study will investigate whether there is any effect of GW273225 upon the components of combined oral contraceptive, and also whether taking oral contraceptives affects the pharmacokinetics (PK) of GW273225.
26 healthy female subjects, aged 18-45 years will take an oral contraceptive (150ug levonorgestrel and 30ug ethinylestrdiol; The study will include a screening period, two cycles on oral contraceptive with GW273225 at 25 mg once per day administered from the start of the second COC cycle for 47 days. There will be a follow-up visit 14-21 days later.
- Conditions
- Bipolar Disorder
- Being tested
- GW273225, COC
- Keywords
- Gw273225, Oral Contraceptive Interaction
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW273225Drug
GW273225 will be available as 25 milligram tablets.
COCDrug
COC will consist of Microgynon 30 which is available as ethinylestradiol 30 micrograms/levonorgestrel 150 micrograms beige color, sugar-coated tablets.
| Study group | Role | What they receive |
|---|---|---|
| Sequence ABC | Experimental | All subjects will receive the treatment sequence ABC where A=combined oral contraceptive pill (COC), B=COC plus GW273225 and C=GW273225. COC will be administered in two cycles that is, cycle 1 (Days 1-21) and cycle 2 (Days 29-49) of the study. The cycles will be separated by a 7 day washout period. GW273225 will be administered at a dose of one 25 milligram tablet once daily on Days 29-75 of the study. Receives: Drug: GW273225; Drug: COC |
What is being measured
The primary outcome is the main question the study is designed to answer.
0-24hrs PK of oral contraceptive components
Measured: 0-24hrs
Secondary outcomes (8)
0-24hrs PK of GW273225 Hormone levels with co-administration of oral contraceptive and GW273225
Measured: 0-24hrs
blood drug levels of GW273225 in the presence or absence of the Combined Oral Contraceptive (COC)
Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post dosing on Day 49 and Day 75
blood levels of ethinylestradiol and levonorgestrel of the COC in the presence or absence of GW273225.
Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post dosing on Day 21 and Day 49
blood levels of FSH, LH and progesterone
Measured: Up to Day 45
blood levels of Oestradiol and SBHG
Measured: Up to Day 45
Electrocardiogram (ECG) recordings
Measured: Up to Day 96
Adverse events
Measured: Up to Day 96
Vital signs
Measured: Up to Day 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2007 (estimated)
- Study start7 Mar 2007
- Primary completion16 Nov 2007
- Study completion16 Nov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00483535
- Sponsor's protocol ID
- NEC107110
- Status last verified
- Aug 2017
- First submitted
- 6 Jun 2007
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Repeat Dose Study to Investigate the Effect of Co-administration of the Combined Oral Contraceptive Pill (COC) and GW273225 on the Pharmacokinetics of the COC and to Investigate the Effects of the COC on the Pharmacokinetics of GW273225 in Healthy Female Subjects
- ClinicalTrials.gov ID
- NCT00483535
- Acronym / sponsor ID
- NEC107110
- Conditions
- Bipolar Disorder
- Keywords
- Gw273225, Oral Contraceptive Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 12 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2007 (actual)
- Primary completion
- 16 Nov 2007 (actual)
- Study completion
- 16 Nov 2007 (actual)
- First posted
- 7 Jun 2007 (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.
GW273225 is in development for epilepsy and bipolar disorder and can affect women of child bearing potential. A clear understanding of the potential interaction between oral contraceptives and GW273225 is therefore important for clinical investigation of GW273225 in a large number of patients. This study will investigate whether there is any effect of GW273225 upon the components of combined oral contraceptive, and also whether taking oral contraceptives affects the pharmacokinetics (PK) of GW273225.
26 healthy female subjects, aged 18-45 years will take an oral contraceptive (150ug levonorgestrel and 30ug ethinylestrdiol; The study will include a screening period, two cycles on oral contraceptive with GW273225 at 25 mg once per day administered from the start of the second COC cycle for 47 days. There will be a follow-up visit 14-21 days later.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sequence ABC | Experimental | Drug: GW273225, Drug: COCAll subjects will receive the treatment sequence ABC where A=combined oral contraceptive pill (COC), B=COC plus GW273225 and C=GW273225. COC will be administered in two cycles that is, cycle 1 (Days 1-21) and cycle 2 (Days 29-49) of the study. The cycles will be separated by a 7 day washout period. GW273225 will be administered at a dose of one 25 milligram tablet once daily on Days 29-75 of the study. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy female subjects aged between 18 and 45 years, inclusive.
- Body weight >50 kg and Body Mass Index (BMI) within the range 19-29.9 kg/m2 inclusive.
- Female subjects of child bearing potential will be eligible to participate if they are established on a Microgynon 30 or Ovranette for the previous month
- If taking a similar ethinyl oestradiol dose (30 or 35 mcg) combined with a progestogen at fixed dose for 21 days then willing to switch to Microgynon 30
- Subjects will use additional contraception as described in the protocol. One of the methods listed in the protocol is acceptable in conjunction with COC as the method of contraception if there is indisputable data that it is >99% effective, otherwise it should be used with a barrier method (condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository).
Key exclusion criteria (15 listed)
- History or evidence of drug or alcohol abuse within six months of study start.
- Weekly alcohol intake of more than 14 units or an average daily intake of greater than 2 units.
- Female subject pregnant (positive serum human chorionic gonadotrophin (hCG) test at screening) or lactating. HIV, Chronic hepatitis B and C, as evidenced by positive Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody
- Subject has received prescribed or non-prescribed medication (including vitamins and herbal remedies) within 14 days prior to day 1 which in the opinion of the investigator, could have interfered with the study procedures or compromised safety.
- History of gastro-intestinal, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
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 |
|---|---|---|
| GW273225GW273225 will be available as 25 milligram tablets. | Drug | Sequence ABC |
| COCCOC will consist of Microgynon 30 which is available as ethinylestradiol 30 micrograms/levonorgestrel 150 micrograms beige color, sugar-coated tablets. | Drug | Sequence ABC |
Primary outcome
0-24hrs PK of oral contraceptive components
Time frame: 0-24hrs
8 secondary outcomes
0-24hrs PK of GW273225 Hormone levels with co-administration of oral contraceptive and GW273225
Time frame: 0-24hrs
blood drug levels of GW273225 in the presence or absence of the Combined Oral Contraceptive (COC)
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post dosing on Day 49 and Day 75
blood levels of ethinylestradiol and levonorgestrel of the COC in the presence or absence of GW273225.
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post dosing on Day 21 and Day 49
blood levels of FSH, LH and progesterone
Time frame: Up to Day 45
blood levels of Oestradiol and SBHG
Time frame: Up to Day 45
Electrocardiogram (ECG) recordings
Time frame: Up to Day 96
Adverse events
Time frame: Up to Day 96
Vital signs
Time frame: Up to Day 96
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
- Results for study 107110 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
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 GW273225 and COC in people with Bipolar Disorder, run by GlaxoSmithKline 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 11 inclusion and 15 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: stopped early, as of the sponsor's last update on 8 Aug 2017. 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 was stopped early. Results are not available in the source record.
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?
0-24hrs PK of oral contraceptive components (time frame: 0-24hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Aug 2017.