Depressive Disorder and Anxiety DisordersPhase 1NCT00703547
A First Time in Human Study of GSK586529 in Healthy Volunteers
A Phase 1 study testing GSK586529 capsules and GSK586529 tablets in people with Depressive Disorder and Anxiety Disorders, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
A single blind, randomized, placebo-controlled, crossover study in twenty four healthy male subjects. Subjects will be divided into two cohorts with alternate panel design. The study is investigating the safety, tolerability and pharmacokinetics of single oral escalating doses of GSK586529. 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
- Depressive Disorder and Anxiety Disorders
- What is being tested?
- GSK586529 capsules and GSK586529 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Jan 2008to 11 Apr 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 aged 18-45 years, inclusive.
- Healthy subjects, defined as individuals who are free from clinically significant illness or disease as determined by their (and familial) medical and psychiatric history, physical examination, laboratory studies, and other tests.
- Body weight >/= 50 kg (110 lbs) and BMI within the range 18.5-29.9 kg/m2 inclusive.
- Demonstrates no evidence of active disease, physical or 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).
- Normal electrocardiogram (subjects must have no clinically significant abnormalities on a 12-lead ECG and a 24 hour Holter ECG).
- Read, comprehend, and write English at a sufficient level to complete study-related materials.
Who cannot join
- As a result of any of the medical interview, physical examination, evaluation of mental state and psychiatric history or screening investigations the physician responsible considers the subject unfit for the study.
- The subject has a positive pre-study drug/alcohol screen.
- A positive pre-study HIV, Hepatitis B surface antigen or positive Hepatitis C antibody
- The subject has a history of psychiatric illness.
- Any history of suicidal attempts or behavior.
- Abuse of alcohol defined as an average weekly intake of greater than 21 units or an average daily intake of greater than three units..
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- Consumption of grapefruit juice or grapefruit within 14 days prior to the first dose of study medication.
- Any subject who is not prepared to eat the standard meals provided by the clinic or is a vegetarian.
- 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.
- Clinically significant abnormal; total and free testosterone, LH, FSH, ACTH or cortisol, or TSH or T4 values at screening/baseline
- LFTs elevated
- Any other clinically significant laboratory abnormality
- The subject has a screening ECG with parameters outside ranges defined in the protocol will also be excluded.
- History of long QT syndrome (personal or family) or other cardiac conduction disorder, or other clinically significant cardiac disease.
- The subject has received an investigational drug or participated in any other research trial within 3 months or 5 half-lives, or twice the duration of the biological effect of any drug(whichever is longer) prior to the first dose of study medication.
- 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.
- Donation of more than 500 mL blood within the 3 months before dosing.
- An unwillingness of male subjects to abstain from sexual intercourse with pregnant or lactating women from the time of the first dose of study medication until 90 days following administration of the last dose of study medication
- An unwillingness of the male subject to use a condom/spermicide in addition to having their female partner use another form of contraception if the woman could become pregnant from the time of the first dose of study medication until 90 days following administration of the last dose of study medication.
- Current or recent (within one year) gastrointestinal disease; a history of malabsorption, esophageal reflux, peptic ulcer disease, irritable bowel syndrome; frequent (more than once a week) occurrence of heartburn; or any surgical intervention (e.g., cholecysectomy) which would be expected to influence the absorption of drugs.
- 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 60mmHg or greater than 90mmHg; or a radial pulse rate less than 40bpm or more than 90bpm.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Blind, Randomized, Placebo Controlled, Crossover Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single Oral Escalating Doses of GSK586529 in Healthy Volunteers
A single blind, randomized, placebo-controlled, crossover study in twenty four healthy male subjects. Subjects will be divided into two cohorts with alternate panel design. The study is investigating the safety, tolerability and pharmacokinetics of single oral escalating doses of GSK586529.
- Being tested
- GSK586529 capsules, GSK586529 tablets, Placebo
- Keywords
- Depression
- Medical subject headings
- Depressive Disorder, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK586529 capsulesDrug
GSK586529 will be provided as white gelatin capsule with a dose of 3 milligrams.
GSK586529 tabletsDrug
GSK586529 will be provided as a yellow film-coated tablets for oral administration at three different strengths 10 milligrams, 60 milligrams and 120 milligrams.
PlaceboDrug
Placebo tablets and capsules will be provided to subjects.
| Study group | Role | What they receive |
|---|---|---|
| Subjects receiving treatment in cohort 1 | Experimental | Subjects will receive one of the following sequences; ABDF,BADF, BDAF or BDFA (A=Placebo, B= GSK586529 dose 1 (3 milligrams), D = GSK586529 dose 3, F = GSK586529 dose 5). Receives: Drug: GSK586529 capsules; Drug: GSK586529 tablets; Drug: Placebo |
| Subjects receiving treatment in cohort 2 | Experimental | Subjects will receive one of the following sequences; ACEG,CAEG, CEAG or CEGA (A = Placebo, C= GSK586529 dose 2, E = GSK586529 dose 4, G = GSK586529 dose 6) Receives: Drug: GSK586529 capsules; Drug: GSK586529 tablets; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics
Measured: Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
Secondary outcomes (2)
Blood levels of GSK586529 to determine pharmacokinetic parameters
Measured: Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
Urinary recovery of GSK586529
Measured: Pre-dose, 0-6, 6-12, 12-24, 24-48, 48-72 and 72-96 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2008 (estimated)
- Study start28 Jan 2008
- Primary completion11 Apr 2008
- Study completion11 Apr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder and Anxiety DisordersStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Enrolment
- 21 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
- NCT00703547
- Sponsor's protocol ID
- CRZ107432
- Status last verified
- Aug 2017
- First submitted
- 14 Apr 2008
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Blind, Randomized, Placebo Controlled, Crossover Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single Oral Escalating Doses of GSK586529 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00703547
- Acronym / sponsor ID
- CRZ107432
- Keywords
- Depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2008 (actual)
- Primary completion
- 11 Apr 2008 (actual)
- Study completion
- 11 Apr 2008 (actual)
- First posted
- 23 Jun 2008 (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.
A single blind, randomized, placebo-controlled, crossover study in twenty four healthy male subjects. Subjects will be divided into two cohorts with alternate panel design. The study is investigating the safety, tolerability and pharmacokinetics of single oral escalating doses of GSK586529.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects receiving treatment in cohort 1 | Experimental | Drug: GSK586529 capsules, Drug: GSK586529 tablets, Drug: PlaceboSubjects will receive one of the following sequences; ABDF,BADF, BDAF or BDFA (A=Placebo, B= GSK586529 dose 1 (3 milligrams), D = GSK586529 dose 3, F = GSK586529 dose 5). |
| Subjects receiving treatment in cohort 2 | Experimental | Drug: GSK586529 capsules, Drug: GSK586529 tablets, Drug: PlaceboSubjects will receive one of the following sequences; ACEG,CAEG, CEAG or CEGA (A = Placebo, C= GSK586529 dose 2, E = GSK586529 dose 4, G = GSK586529 dose 6) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy males aged 18-45 years, inclusive.
- Healthy subjects, defined as individuals who are free from clinically significant illness or disease as determined by their (and familial) medical and psychiatric history, physical examination, laboratory studies, and other tests.
- Body weight >/= 50 kg (110 lbs) and BMI within the range 18.5-29.9 kg/m2 inclusive.
- Demonstrates no evidence of active disease, physical or mental impairment.
- Self-administered Beck Depression Inventory II scale total score no greater than 9, and suicide question score of zero.
Key exclusion criteria (23 listed)
- As a result of any of the medical interview, physical examination, evaluation of mental state and psychiatric history or screening investigations the physician responsible considers the subject unfit for the study.
- The subject has a positive pre-study drug/alcohol screen.
- A positive pre-study HIV, Hepatitis B surface antigen or positive Hepatitis C antibody
- The subject has a history of psychiatric illness.
- Any history of suicidal attempts or behavior.
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 |
|---|---|---|
| GSK586529 capsulesGSK586529 will be provided as white gelatin capsule with a dose of 3 milligrams. | Drug | Subjects receiving treatment in cohort 1, Subjects receiving treatment in cohort 2 |
| GSK586529 tabletsGSK586529 will be provided as a yellow film-coated tablets for oral administration at three different strengths 10 milligrams, 60 milligrams and 120 milligrams. | Drug | Subjects receiving treatment in cohort 1, Subjects receiving treatment in cohort 2 |
| PlaceboPlacebo tablets and capsules will be provided to subjects. | Drug | Subjects receiving treatment in cohort 1, Subjects receiving treatment in cohort 2 |
Primary outcome
Pharmacokinetics
Time frame: Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
2 secondary outcomes
Blood levels of GSK586529 to determine pharmacokinetic parameters
Time frame: Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
Urinary recovery of GSK586529
Time frame: Pre-dose, 0-6, 6-12, 12-24, 24-48, 48-72 and 72-96 hours post-dose
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 22 Aug 2017.
- Results for study CRZ107432 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 GSK586529 capsules and GSK586529 tablets in people with Depressive Disorder and Anxiety Disorders, 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 8 inclusion and 23 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 22 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 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?
Pharmacokinetics (time frame: Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose). 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 22 Aug 2017.