Depressive Disorder and Anxiety DisordersPhase 1NCT00536679

Relative Bioavailability and Food Effect Study for GSK163090 in Healthy Male and Female Volunteers

A Phase 1 study testing GSK163090 capsule, fasted, GSK163090 Tablet, fasted and GSK163090 Tablet, fed in people with Depressive Disorder and Anxiety Disorders, run by GlaxoSmithKline at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The study will consist of a screening period, 3 treatment periods and a post-treatment follow-up. In each of the 3 treatment periods, subjects will receive a single oral dose of GSK163090 in the fed or fasted state, followed by a 7-day wash-out period between each dose Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Depressive Disorder and Anxiety Disorders
What is being tested?: GSK163090 capsule, fasted, GSK163090 Tablet, fasted and GSK163090 Tablet, fed
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteGermany
Study dates: 20 Sep 2007to 5 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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male or female subjects between the ages of 18 and 55 years inclusive.
If female, the subject is eligible to enter and participate in this study if she is not lactating and is of Non-childbearing potential or
Child-bearing potential, has a negative pregnancy test at both screen and baseline and agrees to adequate contraception:
Body weight ≥ 50 kg and body mass index (BMI) between 18.5 - 29.9 kg/m2 inclusive.
Capable of giving informed consent and can comply with the study requirements and timetable.
Self-administered Beck Depression Inventory II scale total score no greater than 9, and suicide question score of zero.

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The subject must be able to read, comprehend and record information.
A signed and dated written informed consent is obtained from the subject.
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

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.
The subject has a history of a drug or other allergy which in the opinion of the physician responsible contraindicates their participation in the study.
The subject is currently participating or has participated in a clinical trial with a new chemical entity during the previous 4 months or any other trial during the previous 3 months.
The subject has a screening ECG with values outside of protocoled ranges
The subject has a pulse rate <45 or >100 bpm and a systolic blood pressure >150 and <90 and a diastolic blood pressure >90 and <50.
History of long QT syndrome (personal or family) or other cardiac conduction disorder, or other clinically significant cardiac disease.

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The subject has liver function tests (LFT) elevated >1.5 times above the reference range at pre-study screening that remain elevated with a repeat LFT.
Any other clinically significant laboratory abnormality.
Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) 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.
Abuse of alcohol defined as an average weekly intake of greater than 21 units for males and 14 units for females or an average daily intake of greater than 3 units for males and 2 units for females. 1 unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine.
Consumption of grapefruit juice or grapefruit within 7 days prior to the first dose of study medication until collection of the last PK sample.
The subject is unable to abstain from strenuous physical activity for 48 h prior to screening and follow up and for 48 h prior to and 48 h after each treatment period.
Where participation in study would result in donation of blood in excess of 500 mL within a 90 day period
An unwillingness of male subjects to abstain from, or use adequate contraception during, 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 OR An unwillingness of the male subject to use a adequate contraception 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, irritable bowel syndrome; frequent (more than once a week) occurrence of heartburn; or any surgical intervention (e.g., cholecystectomy) which would be expected to influence the absorption of drugs.
The subject has a history of psychiatric illness
Any history of suicidal attempts or behavior.
The subject has tested positive for hepatitis C antibody or hepatitis B surface antigen.
The subject has tested positive for HIV.
The subject has a past history of drug abuse or has tested positive for urine drugs of abuse at pre-study screening.
The subject has any history of serotonin syndrome.

Trial locations and contacts

1 site in 1 country.

Germany1 site

GSK Investigational Site
Neuss, North Rhine-Westphalia, 41460

Other trials in Germany

About this study

Official title: An Open Label, Randomised, Single Dose, Three-way Crossover Study to Investigate the Relative Bioavailability of Two Different Formulations of GSK163090 and the Effect of Food on the Pharmacokinetics of a Tablet Formulation in Healthy Male and Female Volunteers

Conditions: Depressive Disorder and Anxiety Disorders
Being tested: GSK163090 capsule, fasted, GSK163090 Tablet, fasted, GSK163090 Tablet, fed
Keywords: Relative Bioavailability, Randomised, GSK163090, Food Effect
Medical subject headings: Depressive Disorder, Anxiety Disorders

What participants receive

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

GSK163090 capsule, fastedDrug
Also called GSK163090
GSK163090 will be available as 1 mg hard gelatine white/white opaque capsules. Each subject will receive a single, oral dose of the study medication on the morning of Day 1. The study drug will be administered with approximately 240 milliliters (mL) of water.
GSK163090 Tablet, fastedDrug
GSK163090 will be available as 1 mg white coated round tablet. Each subject will receive a single, oral dose of the study medication on the morning of Day 1. The study drug will be administered with approximately 240 mL of water.
GSK163090 Tablet, fedDrug
GSK163090 will be available as 1 mg white coated round tablet. Each subject will receive a single, oral dose of the study medication on the morning of Day 1. The study drug will be administered with Food and Drug Administration (FDA) high fat breakfast.

Study groups in NCT00536679
Study group	Role	What they receive
Sequence ABC	Experimental	Subjects will be randomized to sequence ABC, where A=1 milligram (mg) GSK163090 Capsule, Fasted, B=1 mg GSK163090 Tablet, Fasted and C=1 mg GSK163090 Tablet, Fed. In each of the 3 treatment periods, subjects will receive a single oral dose of GSK163090 in the fed or fasted state, followed by a 7-day wash-out period between each dose. Receives: Drug: GSK163090 capsule, fasted; Drug: GSK163090 Tablet, fasted; Drug: GSK163090 Tablet, fed
Sequence ACB	Experimental	Subjects will be randomized to sequence ACB, where A=1 mg GSK163090 Capsule, Fasted, B=1 mg GSK163090 Tablet, Fasted and C=1 mg GSK163090 Tablet, Fed. In each of the 3 treatment periods, subjects will receive a single oral dose of GSK163090 in the fed or fasted state, followed by a 7-day wash-out period between each dose. Receives: Drug: GSK163090 capsule, fasted; Drug: GSK163090 Tablet, fasted; Drug: GSK163090 Tablet, fed
Sequence BAC	Experimental	Subjects will be randomized to sequence BAC, where A=1 mg GSK163090 Capsule, Fasted, B=1 mg GSK163090 Tablet, Fasted and C=1 mg GSK163090 Tablet, Fed. In each of the 3 treatment periods, subjects will receive a single oral dose of GSK163090 in the fed or fasted state, followed by a 7-day wash-out period between each dose. Receives: Drug: GSK163090 capsule, fasted; Drug: GSK163090 Tablet, fasted; Drug: GSK163090 Tablet, fed
Sequence BCA	Experimental	Subjects will be randomized to sequence BCA, where A=1 mg GSK163090 Capsule, Fasted, B=1 mg GSK163090 Tablet, Fasted and C=1 mg GSK163090 Tablet, Fed. In each of the 3 treatment periods, subjects will receive a single oral dose of GSK163090 in the fed or fasted state, followed by a 7-day wash-out period between each dose. Receives: Drug: GSK163090 capsule, fasted; Drug: GSK163090 Tablet, fasted; Drug: GSK163090 Tablet, fed
Sequence CAB	Experimental	Subjects will be randomized to sequence CAB, where A=1 mg GSK163090 Capsule, Fasted, B=1 mg GSK163090 Tablet, Fasted and C=1 mg GSK163090 Tablet, Fed. In each of the 3 treatment periods, subjects will receive a single oral dose of GSK163090 in the fed or fasted state, followed by a 7-day wash-out period between each dose. Receives: Drug: GSK163090 capsule, fasted; Drug: GSK163090 Tablet, fasted; Drug: GSK163090 Tablet, fed
Sequence CBA	Experimental	Subjects will be randomized to sequence CBA, where A=1 mg GSK163090 Capsule, Fasted, B=1 mg GSK163090 Tablet, Fasted and C=1 mg GSK163090 Tablet, Fed. In each of the 3 treatment periods, subjects will receive a single oral dose of GSK163090 in the fed or fasted state, followed by a 7-day wash-out period between each dose. Receives: Drug: GSK163090 capsule, fasted; Drug: GSK163090 Tablet, fasted; Drug: GSK163090 Tablet, fed

What is being measured

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

Pharmacokinetic parameters for GSK163090. Pharmacokinetic blood samples will be collected up to 72 hours post-dose following each dosing session.
Measured: 72 hours post-dose following each dosing session.

Secondary outcomes (1)

Additional pharmacokinetic parameters, safety, and tolerability.
Measured: 72 hours post-dose following each dosing session.

Timeline

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

20 Sep 20075 Nov 2007

First posted28 Sep 2007 (estimated)
Study start20 Sep 2007
Primary completion5 Nov 2007
Study completion5 Nov 2007

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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00536679
Sponsor's protocol ID: 103268
Status last verified: Aug 2017
First submitted: 27 Sep 2007
Last updated: 3 Aug 2017
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Randomised, Single Dose, Three-way Crossover Study to Investigate the Relative Bioavailability of Two Different Formulations of GSK163090 and the Effect of Food on the Pharmacokinetics of a Tablet Formulation in Healthy Male and Female Volunteers
ClinicalTrials.gov ID: NCT00536679
Acronym / sponsor ID: 103268
Conditions: Depressive Disorder and Anxiety Disorders
Keywords: Relative Bioavailability, Randomised, GSK163090, Food Effect
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 20 Sep 2007 (actual)
Primary completion: 5 Nov 2007 (actual)
Study completion: 5 Nov 2007 (actual)
First posted: 28 Sep 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Sequence ABC	Experimental	Drug: GSK163090 capsule, fasted, Drug: GSK163090 Tablet, fasted, Drug: GSK163090 Tablet, fedSubjects will be randomized to sequence ABC, where A=1 milligram (mg) GSK163090 Capsule, Fasted, B=1 mg GSK163090 Tablet, Fasted and C=1 mg GSK163090 Tablet, Fed. In each of the 3 treatment periods, subjects will receive a single oral dose of GSK163090 in the fed or fasted state, followed by a 7-day wash-out period between each dose.
Sequence ACB	Experimental	Drug: GSK163090 capsule, fasted, Drug: GSK163090 Tablet, fasted, Drug: GSK163090 Tablet, fedSubjects will be randomized to sequence ACB, where A=1 mg GSK163090 Capsule, Fasted, B=1 mg GSK163090 Tablet, Fasted and C=1 mg GSK163090 Tablet, Fed. In each of the 3 treatment periods, subjects will receive a single oral dose of GSK163090 in the fed or fasted state, followed by a 7-day wash-out period between each dose.
Sequence BAC	Experimental	Drug: GSK163090 capsule, fasted, Drug: GSK163090 Tablet, fasted, Drug: GSK163090 Tablet, fedSubjects will be randomized to sequence BAC, where A=1 mg GSK163090 Capsule, Fasted, B=1 mg GSK163090 Tablet, Fasted and C=1 mg GSK163090 Tablet, Fed. In each of the 3 treatment periods, subjects will receive a single oral dose of GSK163090 in the fed or fasted state, followed by a 7-day wash-out period between each dose.
Sequence BCA	Experimental	Drug: GSK163090 capsule, fasted, Drug: GSK163090 Tablet, fasted, Drug: GSK163090 Tablet, fedSubjects will be randomized to sequence BCA, where A=1 mg GSK163090 Capsule, Fasted, B=1 mg GSK163090 Tablet, Fasted and C=1 mg GSK163090 Tablet, Fed. In each of the 3 treatment periods, subjects will receive a single oral dose of GSK163090 in the fed or fasted state, followed by a 7-day wash-out period between each dose.
Sequence CAB	Experimental	Drug: GSK163090 capsule, fasted, Drug: GSK163090 Tablet, fasted, Drug: GSK163090 Tablet, fedSubjects will be randomized to sequence CAB, where A=1 mg GSK163090 Capsule, Fasted, B=1 mg GSK163090 Tablet, Fasted and C=1 mg GSK163090 Tablet, Fed. In each of the 3 treatment periods, subjects will receive a single oral dose of GSK163090 in the fed or fasted state, followed by a 7-day wash-out period between each dose.
Sequence CBA	Experimental	Drug: GSK163090 capsule, fasted, Drug: GSK163090 Tablet, fasted, Drug: GSK163090 Tablet, fedSubjects will be randomized to sequence CBA, where A=1 mg GSK163090 Capsule, Fasted, B=1 mg GSK163090 Tablet, Fasted and C=1 mg GSK163090 Tablet, Fed. In each of the 3 treatment periods, subjects will receive a single oral dose of GSK163090 in the fed or fasted state, followed by a 7-day wash-out period between each dose.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

Healthy male or female subjects between the ages of 18 and 55 years inclusive.
If female, the subject is eligible to enter and participate in this study if she is not lactating and is of Non-childbearing potential or
Child-bearing potential, has a negative pregnancy test at both screen and baseline and agrees to adequate contraception:
Body weight ≥ 50 kg and body mass index (BMI) between 18.5 - 29.9 kg/m2 inclusive.
Capable of giving informed consent and can comply with the study requirements and timetable.

Key exclusion criteria (21 listed)

As a result of any of the medical interview, physical examination or screening investigations the physician responsible considers the subject unfit for the study.
The subject has a history of a drug or other allergy which in the opinion of the physician responsible contraindicates their participation in the study.
The subject is currently participating or has participated in a clinical trial with a new chemical entity during the previous 4 months or any other trial during the previous 3 months.
The subject has a screening ECG with values outside of protocoled ranges
The subject has a pulse rate <45 or >100 bpm and a systolic blood pressure >150 and <90 and a diastolic blood pressure >90 and <50.

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
GSK163090 capsule, fastedAlso: GSK163090GSK163090 will be available as 1 mg hard gelatine white/white opaque capsules. Each subject will receive a single, oral dose of the study medication on the morning of Day 1. The study drug will be administered with approximately 240 milliliters (mL) of water.	Drug	Sequence ABC, Sequence ACB, Sequence BAC, Sequence BCA, Sequence CAB, Sequence CBA
GSK163090 Tablet, fastedGSK163090 will be available as 1 mg white coated round tablet. Each subject will receive a single, oral dose of the study medication on the morning of Day 1. The study drug will be administered with approximately 240 mL of water.	Drug	Sequence ABC, Sequence ACB, Sequence BAC, Sequence BCA, Sequence CAB, Sequence CBA
GSK163090 Tablet, fedGSK163090 will be available as 1 mg white coated round tablet. Each subject will receive a single, oral dose of the study medication on the morning of Day 1. The study drug will be administered with Food and Drug Administration (FDA) high fat breakfast.	Drug	Sequence ABC, Sequence ACB, Sequence BAC, Sequence BCA, Sequence CAB, Sequence CBA

Primary outcome

Pharmacokinetic parameters for GSK163090. Pharmacokinetic blood samples will be collected up to 72 hours post-dose following each dosing session.
Time frame: 72 hours post-dose following each dosing session.

1 secondary outcome

Additional pharmacokinetic parameters, safety, and tolerability.
Time frame: 72 hours post-dose following each dosing session.

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 3 Aug 2017.
Results for study 103268 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?

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 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: finished, as of the sponsor's last update on 3 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 Germany. 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?

Pharmacokinetic parameters for GSK163090. Pharmacokinetic blood samples will be collected up to 72 hours post-dose following each dosing session. (time frame: 72 hours post-dose following each dosing session.). 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 NCT00536679.

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 3 Aug 2017.