Autoimmune DiseasesPhase 1NCT00975936
Phase 0 Microdose Study
A Phase 1 study testing [14C]-GSK706769 and Ketoconazole in people with Autoimmune Diseases, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This study is a methodology study to evaluate a microdose strategy for Drug-Drug Interaction (DDI) which will be useful in the evaluation of the backup compounds for GSK706769, as well as possibly other assets. The safety, tolerability and pharmacokinetics will be evaluated in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Autoimmune Diseases
- What is being tested?
- [14C]-GSK706769 and Ketoconazole
- 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 States
- Study dates
- 21 Sep 2009to 12 Nov 2009
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males 18-50 years of age inclusive, at the time of signing the informed consent.
- AST, ALT, alkaline phosphatase and bilirubin less than or equal to 1.5x Upper Limit of Normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Signed written informed consent prior to beginning study-related procedures. Subjects must understand the aims, investigational procedures and possible consequences of the study and must be able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Male subjects must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until 7 days post-last dose.
- Body weight greater than or equal to 50 kg (110 pounds) and body mass index (BMI) between 19 and 35 kg/m2 (inclusive)
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Average QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
Who cannot join
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- A positive pre-study drug/alcohol screen.
- A positive test for HIV antibody.
- History of regular alcohol consumption within 6 months of the study defined in the protocol.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
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- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- History of sensitivity to any of the study medications (including Ketoconazole), or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Any medical or surgical conditions that might significantly interfere with the gastrointestinal absorption, distribution, metabolism, or excretion of the study drugs (eg, gastrectomy).
- Subjects who have been involved in a 14C human research study within the previous 12 months.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subject is mentally or legally incapacitated.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication until the completion of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Human Phase 0, Microdose Drug-Drug Interaction Study With [14C]-GSK706769 and Ketoconazole in Healthy Male Volunteers
This study is a methodology study to evaluate a microdose strategy for Drug-Drug Interaction (DDI) which will be useful in the evaluation of the backup compounds for GSK706769, as well as possibly other assets. The safety, tolerability and pharmacokinetics will be evaluated in healthy adult subjects. This will be an open-label fixed-sequence 2-period study in healthy male volunteers after oral administration of [14C]-GSK706769 alone and in the presence of Ketoconazole.
- Conditions
- Autoimmune Diseases
- Being tested
- [14C]-GSK706769, Ketoconazole
- Keywords
- Microdose, Drug-Drug Interaction, Ketoconazole, Phase 0
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-GSK706769Drug
50µg [14C]-GSK706769 containing 250 nCi
KetoconazoleDrug
200 mg Ketoconazole (Q12)
| Study group | Role | What they receive |
|---|---|---|
| [14C]-GSK706769 | Experimental | Single dose of 50µg [14C]-GSK706769 containing 250 nCi Receives: Drug: [14C]-GSK706769 |
| [14C]-GSK706769 + Ketoconazole | Experimental | An oral, 5-day repeat dose of 200 mg Ketoconazole (Q12) with a concomitant single oral dose of 50 µg [14C]-GSK706769 containing 250 nCi on day 3. Receives: Drug: [14C]-GSK706769; Drug: Ketoconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax, Tmax, AUC0-t. AUC0-infinity, total plasma clearance (CL/F), apparent volume of distribution (V/F) and terminal phase half-life (t1/2) will also be calculated where data permit.
Measured: Throughout study
Secondary outcomes (1)
Clinical safety and tolerability data including spontaneous Adverse Event reporting, ECGs, vital signs, nursing/physician observation, physical examination and clinical laboratory values.
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2009 (estimated)
- Study start21 Sep 2009
- Primary completion12 Nov 2009
- Study completion12 Nov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies 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
- Basic science
- 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
- NCT00975936
- Sponsor's protocol ID
- 113191
- Status last verified
- Jun 2017
- First submitted
- 11 Sep 2009
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Human Phase 0, Microdose Drug-Drug Interaction Study With [14C]-GSK706769 and Ketoconazole in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT00975936
- Acronym / sponsor ID
- 113191
- Conditions
- Autoimmune Diseases
- Keywords
- Microdose, Drug-Drug Interaction, Ketoconazole, Phase 0
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2009 (actual)
- Primary completion
- 12 Nov 2009 (actual)
- Study completion
- 12 Nov 2009 (actual)
- First posted
- 14 Sep 2009 (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.
This study is a methodology study to evaluate a microdose strategy for Drug-Drug Interaction (DDI) which will be useful in the evaluation of the backup compounds for GSK706769, as well as possibly other assets. The safety, tolerability and pharmacokinetics will be evaluated in healthy adult subjects. This will be an open-label fixed-sequence 2-period study in healthy male volunteers after oral administration of [14C]-GSK706769 alone and in the presence of Ketoconazole.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| [14C]-GSK706769 | Experimental | Drug: [14C]-GSK706769Single dose of 50µg [14C]-GSK706769 containing 250 nCi |
| [14C]-GSK706769 + Ketoconazole | Experimental | Drug: [14C]-GSK706769, Drug: KetoconazoleAn oral, 5-day repeat dose of 200 mg Ketoconazole (Q12) with a concomitant single oral dose of 50 µg [14C]-GSK706769 containing 250 nCi on day 3. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Males 18-50 years of age inclusive, at the time of signing the informed consent.
- AST, ALT, alkaline phosphatase and bilirubin less than or equal to 1.5x Upper Limit of Normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Signed written informed consent prior to beginning study-related procedures. Subjects must understand the aims, investigational procedures and possible consequences of the study and must be able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Male subjects must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until 7 days post-last dose.
Key exclusion criteria (16 listed)
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- A positive pre-study drug/alcohol screen.
- A positive test for HIV antibody.
- History of regular alcohol consumption within 6 months of the study defined in the protocol.
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 |
|---|---|---|
| [14C]-GSK70676950µg [14C]-GSK706769 containing 250 nCi | Drug | [14C]-GSK706769, [14C]-GSK706769 + Ketoconazole |
| Ketoconazole200 mg Ketoconazole (Q12) | Drug | [14C]-GSK706769 + Ketoconazole |
Primary outcome
Cmax, Tmax, AUC0-t. AUC0-infinity, total plasma clearance (CL/F), apparent volume of distribution (V/F) and terminal phase half-life (t1/2) will also be calculated where data permit.
Time frame: Throughout study
1 secondary outcome
Clinical safety and tolerability data including spontaneous Adverse Event reporting, ECGs, vital signs, nursing/physician observation, physical examination and clinical laboratory values.
Time frame: Throughout study
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 27 Jun 2017.
- Results for study 113191 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 [14C]-GSK706769 and Ketoconazole in people with Autoimmune Diseases, run by GlaxoSmithKline at 1 site in United States.
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 16 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 27 Jun 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 States. 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?
Cmax, Tmax, AUC0-t. AUC0-infinity, total plasma clearance (CL/F), apparent volume of distribution (V/F) and terminal phase half-life (t1/2) will also be calculated where data permit. (time frame: Throughout study). 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 27 Jun 2017.