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Social PhobiaPhase 1NCT00508911

A Study To Evaluate The Effect Of GW876008 On The Pharmacokinetics Of Oral Contraceptive Pills

A Phase 1 study testing GW876008 and COC in people with Social Phobia, run by GlaxoSmithKline at 1 site in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study will be conducted in healthy female volunteers to investigate the effect of GW876008 on the pharmacokinetics of oral contraceptive pills. 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
Social Phobia
What is being tested?
GW876008 and COC
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited Kingdom
Study dates
8 Jun 2007to 22 Oct 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

  • Females of childbearing potential, who:
  • have been taking for at least 3 months a monophasic combined oral contraceptives (COC) (21 repeat-days administration + 7-days washout) containing ethinyloestradiol 30µg and levonorgestrel 150 µg;
  • are willing to continue a monophasic COC containing ethinyloestradiol 30µg and levonorgestrel 150 µg from at least the commencement of their last normal period prior to the first dose of study medication;
  • are willing to continue a monophasic COC containing ethinyloestradiol 30µg and levonorgestrel 150 µg until 14 days after last treatment or until the first normal period (defined as normal for the woman, both in terms of duration and quantity of menses) after last treatment, whichever is the longest.
  • Women should have a regular menstrual cycle of approximately 4 weeks duration in the preceding 3 months.
  • Females of childbearing potential will be required to use other adequate contraception, in addition to the COC
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  • Aged 18-45 years inclusive.
  • Healthy subjects, defined as individuals who are free from clinically significant illness or disease as determined by their medical and psychiatric history (including family), physical examination, laboratory studies, and other tests.
  • Body weight ≥ 45 kg for women and BMI within the range 18.5-29.9 kg/m2 inclusive;
  • Demonstrates no evidence of active disease, physical or significant mental impairment.
  • Self-administered Beck Depression Inventory II scale total score no greater than 9, and suicide question score of zero.
  • Non-smoker (abstinence from smoking for at least 6 months before the start of the study).
  • Agrees to abstain from ingesting caffeine or xanthine-containing products for 24 hours prior to the start of dosing until collection of the final pharmacokinetic sample.
  • Agree to abstain from alcohol for 24 hours prior to the start of dosing until collection of the final pharmacokinetic sample.
  • Normal electrocardiogram (subjects must have no clinically significant abnormalities on a 12-lead ECG and a 24 hour Holter ECG).
  • Hormone assessments must be within normal range, at the pre-study assessment.
  • Agree to remain in the clinic for the time defined in the protocol.
  • Subject who has a history of peptic ulcer disease (PUD) with known aetiology must provide documentation by a gastroenterologist of the aetiology of the PUD and that effective treatment was provided with full eradication of ulcers and symptoms. For such subjects appropriate steps must also have been taken to minimize reoccurrence of risk (i.e. if PUD was nonsteroidal anti-inflammatory drug [NSAID] induced, the subject should no longer be taking NSAID medications; if cause was H. pylori, the subject should have been appropriately treated). Subjects with a history of PUD >10 years ago, without recurrence, may be included after discussion with the medical monitor even if documentation from treating physician is not available or aetiology unclear. See Section 6.3.6 for more details.
  • Signed and dated written informed consent prior to admission to the study.
  • The subject is able to understand and comply with protocol requirements,

Who cannot join

  • As a result of any of the medical interview, physical examination or screening investigations the physician responsible considers the subject unfit for the study.
  • Any clinical condition in which the COC is contra-indicated
  • Female subjects who are currently or planning to become pregnant or lactating (from screening through at least 8 weeks after receiving study drug).
  • The subject has a positive pre-study urine drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
  • A positive pre-study HIV 1/2, Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
  • Any history of suicidal attempts or behaviour.
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  • History of alcohol/drug abuse or dependence within 12 months of the study: history of regular alcohol consumption averaging > 14 drinks/week for women [1 drink is equivalent to (12 g alcohol) = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of 80 proof distilled spirits] within 6 months of screening.
  • Consumption of grapefruit juice or grapefruit within 14 days prior to the first dose of study medication.
  • Any history of an endocrine disorder including, but not limited to, diabetes or disorders of the hypothalamus, pituitary, adrenal, or thyroid glands, or gonadal disorder or dysfunction of the reproductive organs.
  • Pepsinogen I, ACTH, cortisol, TSH, Total T4, Free T4 at screening/baseline outside > 5% of normal range.
  • LFTs elevated above the reference range at pre-study screening that remain elevated with a repeat LFT
  • Any other clinically significant laboratory abnormality.
  • The subject has a screening ECG with values outside the ranges defined in the protocol
  • History of long QT syndrome (personal or family) or other cardiac conduction disorder, or other clinically significant cardiac disease.
  • The subject has participated in a clinical trial and has received a drug or a new chemical entity within 90 days or 5 half-lives, or twice the duration of the biological effect of any drug(whichever is longer) prior to the first dose of current study medication
  • Other than prescribed COC, use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John'sWort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and sponsor the medication will not interfere with the study procedures or compromise subject safety.
  • History or presence of allergy to the study drug or drugs of this class, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation.
  • Where participation in study would result in donation of blood in excess of 500 mL within a 90 day period.
  • Average daily caffeine intake equivalent to > 4 cups of coffee or > 6 cups of tea.
  • A semi-supine systolic blood pressure less than 90mmHg or greater than 140mmHg or a semi-supine diastolic blood pressure of less than 50mmHg or greater than 90mmHg; or a radial pulse rate less than 40bpm or more than 90bpm.
  • Subjects with positive faecal occult blood test.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • GSK Investigational Site

    Harrow, Middlesex, HA13UJ

Other trials in United Kingdom

About this study

Official title: An Open-label, Repeat-dose, Single-sequence Study to Investigate the Effects of Once-daily Repeat Oral Administration of GW876008 125mg on the Pharmacokinetics of the Combined Oral Contraceptive in Female Volunteers

This study will be conducted in healthy female volunteers to investigate the effect of GW876008 on the pharmacokinetics of oral contraceptive pills.

Conditions
Social Phobia
Being tested
GW876008, COC
Keywords
open-label,, oral contraceptive,, Combine Oral Contraceptives,, single-sequence,, volunteers, GW876008,, repeat-dose,, female,, pharmacokinetics,
Medical subject headings
Phobia, Social

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GW876008Drug

    Also called GW876008 Oral Contraceptive

    GW876008 tablets will be available as white to off-white coated tablets. Each subject will receive a single oral dose of GW876008, daily for up to 35 days in Session 2. GW876008 will be administered in the morning with a light breakfast.

  • COCDrug

    COC containing ethinylestradiol 30 microgram and levonorgestrel 150 microgram will be administered in the morning with a light breakfast.

Study groups in NCT00508911
Study groupRoleWhat they receive
Healthy female subjectsExperimentalEach subject will be administered a monophasic combined oral contraceptive (COC) containing ethinylestradiol 30 micrograms and levonorgestrel 150 micrograms for two complete cycles (Day 8 to Day 28) in Session 1. The subjects will be administered COC on Day 8 to Day 28 and GW876008 125 milligrams on Days 1 to 35 in Session 2.
Receives: Drug: GW876008; Drug: COC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood level of oral contraceptive pills

    Measured: measured over 24hrs on Day 28 of Period 1 and 2

Secondary outcomes (6)

  1. 1)PK parameters of oral contraceptives

    Measured: Day 28

  2. 2)PK parameters of GW876008

    Measured: Days 28 and 35 (Period2)

  3. 3)Blood level of sex hormones 4) Frequency of breakthrough bleeding 5) adverse event,12-lead ECG and vital signs and laboratory tests

    Measured: (throughout study)

  4. Ethinylestradiol and levonorgestrel blood levels to determine pharmacokinetic parameter

    Measured: Session 1: Day 28 at pre-dose (-30 mins), 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hours post-dose. Session 2: Day 28 at pre-dose (-30 mins), 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hours post-dose. Days 30-35

  5. Serum concentrations of LH, FSH.

    Measured: Pre-dose on Days 8, 12 and 19

  6. Serum concentration of progesterone and estradiol

    Measured: Pre-dose on Days 25 and 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2007 (estimated)
  2. Study start8 Jun 2007
  3. Primary completion22 Oct 2007
  4. Study completion22 Oct 2007

Resources

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
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00508911
Sponsor's protocol ID
CRH103002
Status last verified
Aug 2017
First submitted
26 Jul 2007
Last updated
4 Aug 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GW876008 and COC in people with Social Phobia, 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 20 inclusion and 21 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 4 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?

Blood level of oral contraceptive pills (time frame: measured over 24hrs on Day 28 of Period 1 and 2). 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 NCT00508911.

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 4 Aug 2017.

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