Hepatitis CPhase 1NCT01458054
Effect of Omeprazole and Ritonavir on GSK2336805 Pharmacokinetics in Healthy Adults
A Phase 1 study testing Cohort 1 (GSK2336805 60mg x 1 dose, Omeprazole 40 mg q24h x 4 days, GSK2336805 60 mg x 1 dose and Omeprazole 40 mg x 1 dose) and Cohort 2 (GSK2336805 30mg x 1 dose, Ritonavir 100mg q12h x 4 days, and Ritonavir 100mg q12h x 1 dose) in people with Hepatitis C, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This study is a Phase I open label drug interaction study to evaluate the effect of omeprazole and ritonavir on GSK2336805. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Cohort 1 (GSK2336805 60mg x 1 dose, Omeprazole 40 mg q24h x 4 days, GSK2336805 60 mg x 1 dose and Omeprazole 40 mg x 1 dose) and Cohort 2 (GSK2336805 30mg x 1 dose, Ritonavir 100mg q12h x 4 days, and Ritonavir 100mg q12h x 1 dose)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2011to 28 Nov 2011
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin greater than or equal to 1.5x Upper Limit of Normal (ULN) (isolated bilirubin greater than 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin less than35%).
- 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 GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. Subjects with values outside the normal range should always be excluded from enrollment.
- Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- A female subject is eligible to participate if she is of:
- Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation, oophorectomy, or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea
- Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until the follow up visit.
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- Body weight greater than or equal to 50 kilograms for men and greater than or equal to 45 kilograms for women. Body mass index (BMI) between 18.5-32 inclusive will be allowed (inclusive).
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- QTcB less than 450; or QTc less than 480 in subjects with Bundle Branch Block
Who cannot join
- 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).
- 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 GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Where participation in the study would result in donation of blood or blood products in excess of 500 milliliters within a 56 day period.
- Pregnant females as determined by positive serum or urine human chorionic gonadotropin test at screening or prior to dosing.
- Lactating females.
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- 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.
- History or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- 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.
- The subject's systolic blood pressure is outside the range of 90-140, or diastolic blood pressure is outside the range of 45-90 or heart rate is outside the range of 50-100 beats per minute (bpm) for female subjects or 45-100 beats per minute for male subjects.
- Exclusion criteria for screening ECG (a single repeat is allowed for eligibility determination):Heart rate less than 45 and greater than 100 bpm for men and less than 50 and greater than 100 bpm for women. PR interval less than 120 and greater than 220. QRS duration less than 70 and greater than 120. QTc interval greater than 450. Evidence of previous myocardial infarction (Does not include ST segment changes associated with repolarization). Any conduction abnormality (including but not specific to left or right complete bundle branch block, AV block [2nd degree or higher], Wolf Parkinson White [WPW] syndrome). Sinus Pauses greater than 3 seconds. Any significant arrhythmia which, in the opinion of the principal investigator and GSK medical monitor, will interfere with the safety for the individual subject. Non-sustained or sustained ventricular tachycardia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1, Open Label Study to Evaluate the Effect of Omeprazole and Ritonavir on GSK2336805 Pharmacokinetics in Healthy Adults
This study is a Phase I open label drug interaction study to evaluate the effect of omeprazole and ritonavir on GSK2336805.
Read the detailed description
This study is a Phase I open label drug interaction study with two objectives. The first objective of this study (Cohort 1) is to determine if the pharmacokinetics of a single dose of GSK2336805 are affected by co-administration with repeat doses of omeprazole, a proton-pump inhibitor that is commonly used by chronic hepatitis C patients .
The second objective of this study (Cohort 2) is to determine if the pharmacokinetics of a single dose of GSK2336805 are affected by co-administration with repeat doses of ritonavir, a HIV protease inhibitor drug that is a potent inhibitor of CYP 3A4.
- Conditions
- Hepatitis C
- Being tested
- Cohort 1 (GSK2336805 60mg x 1 dose, Omeprazole 40 mg q24h x 4 days, GSK2336805 60 mg x 1 dose and Omeprazole 40 mg x 1 dose), Cohort 2 (GSK2336805 30mg x 1 dose, Ritonavir 100mg q12h x 4 days, and Ritonavir 100mg q12h x 1 dose)
- Keywords
- pharmacokinetics, omeprazole, ritonavir, healthy subjects, drug interaction
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cohort 1 (GSK2336805 60mg x 1 dose, Omeprazole 40 mg q24h x 4 days, GSK2336805 60 mg x 1 dose and Omeprazole 40 mg x 1 dose)Drug
GSK2336805 and Omeprazole
Cohort 2 (GSK2336805 30mg x 1 dose, Ritonavir 100mg q12h x 4 days, and Ritonavir 100mg q12h x 1 dose)Drug
GSK2336805 and Ritonavir
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | GSK2336805 60mg x 1 dose (fasted) [Reference Treatment] Receives: Drug: Cohort 1 (GSK2336805 60mg x 1 dose, Omeprazole 40 mg q24h x 4 days, GSK2336805 60 mg x 1 dose and Omeprazole 40 mg x 1 dose) |
| Treatment B | Experimental | Omeprazole 40 mg q24h x 4 days (fed) Receives: Drug: Cohort 1 (GSK2336805 60mg x 1 dose, Omeprazole 40 mg q24h x 4 days, GSK2336805 60 mg x 1 dose and Omeprazole 40 mg x 1 dose) |
| Treatment C | Experimental | GSK2336805 60 mg x 1 dose and Omeprazole 40 mg on Day 1 (fasted) [Test Treatment] Receives: Drug: Cohort 1 (GSK2336805 60mg x 1 dose, Omeprazole 40 mg q24h x 4 days, GSK2336805 60 mg x 1 dose and Omeprazole 40 mg x 1 dose) |
| Treatment D | Experimental | GSK2336805 30mg x 1 dose (fasted) [Reference Treatment] Receives: Drug: Cohort 2 (GSK2336805 30mg x 1 dose, Ritonavir 100mg q12h x 4 days, and Ritonavir 100mg q12h x 1 dose) |
| Treatment E | Experimental | Ritonavir 100mg q12h x 4 days (fed) Receives: Drug: Cohort 2 (GSK2336805 30mg x 1 dose, Ritonavir 100mg q12h x 4 days, and Ritonavir 100mg q12h x 1 dose) |
| Treatment F | Experimental | GSK2336805 30 mg x 1 dose (fasted) and ritonavir 100mg q12h on Day 1 (fasted) [Test Treatment] Receives: Drug: Cohort 2 (GSK2336805 30mg x 1 dose, Ritonavir 100mg q12h x 4 days, and Ritonavir 100mg q12h x 1 dose) |
| Treatment G | Experimental | Ritonavir 100mg q12h x 1 day Receives: Drug: Cohort 2 (GSK2336805 30mg x 1 dose, Ritonavir 100mg q12h x 4 days, and Ritonavir 100mg q12h x 1 dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
area under the plasma concentration time curve from time zero to the last quantifiable time points
PK parameter
Measured: 48 hours
under the plasma concentration time curve from time zero to infinity
PK parameter
Measured: 48 hours
area under the plasma concentration time curve from time zero to 24 hours
PK parameter
Measured: 24 hours
maximum observed concentration
PK parameter
Measured: 48 hours
time to maximum observed concentration
PK parameter
Measured: 48 hours
concentration at 24 hours post-dose
PK parameter
Measured: 24 hours
last measureable concentration
PK parameter
Measured: 48 hours
time of last measurable concentration
PK parameter
Measured: 48 hours
absorption lag time
PK parameter
Measured: 48 hours
the elimination half-life
PK parameter
Measured: 48 hours
apparent oral clearance
PK parameter
Measured: 48 hours
apparent volume of distribution
PK parameter
Measured: 48 hours
Secondary outcomes (5)
Number of subjects with Adverse Events
Safety parameter
Measured: 24 hours
Number of subjects needing concurrent medications
Safety parameter
Measured: 24 hours
Number of subjects with clinical laboratory tests of clinical significance
Safety parameter
Measured: 24 hours
Number of subjects with electrocardiograms with clinically significant values
Safety parameter
Measured: 24 hours
Number of subjects with vital sign measures of clinical significance
Safety parameter
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study start27 Sep 2011
- Primary completion28 Nov 2011
- Study completion28 Nov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 28 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
- NCT01458054
- Sponsor's protocol ID
- 115711
- Status last verified
- Jul 2017
- First submitted
- 6 Oct 2011
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open Label Study to Evaluate the Effect of Omeprazole and Ritonavir on GSK2336805 Pharmacokinetics in Healthy Adults
- ClinicalTrials.gov ID
- NCT01458054
- Acronym / sponsor ID
- 115711
- Conditions
- Hepatitis C
- Keywords
- pharmacokinetics, omeprazole, ritonavir, healthy subjects, drug interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2011 (actual)
- Primary completion
- 28 Nov 2011 (actual)
- Study completion
- 28 Nov 2011 (actual)
- First posted
- 24 Oct 2011 (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 Phase I open label drug interaction study to evaluate the effect of omeprazole and ritonavir on GSK2336805.
Detailed description
This study is a Phase I open label drug interaction study with two objectives. The first objective of this study (Cohort 1) is to determine if the pharmacokinetics of a single dose of GSK2336805 are affected by co-administration with repeat doses of omeprazole, a proton-pump inhibitor that is commonly used by chronic hepatitis C patients .
The second objective of this study (Cohort 2) is to determine if the pharmacokinetics of a single dose of GSK2336805 are affected by co-administration with repeat doses of ritonavir, a HIV protease inhibitor drug that is a potent inhibitor of CYP 3A4.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: Cohort 1 (GSK2336805 60mg x 1 dose, Omeprazole 40 mg q24h x 4 days, GSK2336805 60 mg x 1 dose and Omeprazole 40 mg x 1 dose)GSK2336805 60mg x 1 dose (fasted) [Reference Treatment] |
| Treatment B | Experimental | Drug: Cohort 1 (GSK2336805 60mg x 1 dose, Omeprazole 40 mg q24h x 4 days, GSK2336805 60 mg x 1 dose and Omeprazole 40 mg x 1 dose)Omeprazole 40 mg q24h x 4 days (fed) |
| Treatment C | Experimental | Drug: Cohort 1 (GSK2336805 60mg x 1 dose, Omeprazole 40 mg q24h x 4 days, GSK2336805 60 mg x 1 dose and Omeprazole 40 mg x 1 dose)GSK2336805 60 mg x 1 dose and Omeprazole 40 mg on Day 1 (fasted) [Test Treatment] |
| Treatment D | Experimental | Drug: Cohort 2 (GSK2336805 30mg x 1 dose, Ritonavir 100mg q12h x 4 days, and Ritonavir 100mg q12h x 1 dose)GSK2336805 30mg x 1 dose (fasted) [Reference Treatment] |
| Treatment E | Experimental | Drug: Cohort 2 (GSK2336805 30mg x 1 dose, Ritonavir 100mg q12h x 4 days, and Ritonavir 100mg q12h x 1 dose)Ritonavir 100mg q12h x 4 days (fed) |
| Treatment F | Experimental | Drug: Cohort 2 (GSK2336805 30mg x 1 dose, Ritonavir 100mg q12h x 4 days, and Ritonavir 100mg q12h x 1 dose)GSK2336805 30 mg x 1 dose (fasted) and ritonavir 100mg q12h on Day 1 (fasted) [Test Treatment] |
| Treatment G | Experimental | Drug: Cohort 2 (GSK2336805 30mg x 1 dose, Ritonavir 100mg q12h x 4 days, and Ritonavir 100mg q12h x 1 dose)Ritonavir 100mg q12h x 1 day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin greater than or equal to 1.5x Upper Limit of Normal (ULN) (isolated bilirubin greater than 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin less than35%).
- 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 GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. Subjects with values outside the normal range should always be excluded from enrollment.
- Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- A female subject is eligible to participate if she is of:
- Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation, oophorectomy, or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea
Key exclusion criteria (13 listed)
- 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).
- 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 GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Where participation in the study would result in donation of blood or blood products in excess of 500 milliliters within a 56 day period.
- Pregnant females as determined by positive serum or urine human chorionic gonadotropin test at screening or prior to dosing.
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 |
|---|---|---|
| Cohort 1 (GSK2336805 60mg x 1 dose, Omeprazole 40 mg q24h x 4 days, GSK2336805 60 mg x 1 dose and Omeprazole 40 mg x 1 dose)GSK2336805 and Omeprazole | Drug | Treatment A, Treatment B, Treatment C |
| Cohort 2 (GSK2336805 30mg x 1 dose, Ritonavir 100mg q12h x 4 days, and Ritonavir 100mg q12h x 1 dose)GSK2336805 and Ritonavir | Drug | Treatment D, Treatment E, Treatment F, Treatment G |
Primary outcome
area under the plasma concentration time curve from time zero to the last quantifiable time points
Time frame: 48 hours
PK parameter
under the plasma concentration time curve from time zero to infinity
Time frame: 48 hours
PK parameter
area under the plasma concentration time curve from time zero to 24 hours
Time frame: 24 hours
PK parameter
maximum observed concentration
Time frame: 48 hours
PK parameter
time to maximum observed concentration
Time frame: 48 hours
PK parameter
concentration at 24 hours post-dose
Time frame: 24 hours
PK parameter
last measureable concentration
Time frame: 48 hours
PK parameter
time of last measurable concentration
Time frame: 48 hours
PK parameter
absorption lag time
Time frame: 48 hours
PK parameter
the elimination half-life
Time frame: 48 hours
PK parameter
apparent oral clearance
Time frame: 48 hours
PK parameter
apparent volume of distribution
Time frame: 48 hours
PK parameter
5 secondary outcomes
Number of subjects with Adverse Events
Time frame: 24 hours
Number of subjects needing concurrent medications
Time frame: 24 hours
Number of subjects with clinical laboratory tests of clinical significance
Time frame: 24 hours
Number of subjects with electrocardiograms with clinically significant values
Time frame: 24 hours
Number of subjects with vital sign measures of clinical significance
Time frame: 24 hours
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 21 Jul 2017.
- Results for study 115711 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 Cohort 1 (GSK2336805 60mg x 1 dose, Omeprazole 40 mg q24h x 4 days, GSK2336805 60 mg x 1 dose and Omeprazole 40 mg x 1 dose) and Cohort 2 (GSK2336805 30mg x 1 dose, Ritonavir 100mg q12h x 4 days, and Ritonavir 100mg q12h x 1 dose) in people with Hepatitis C, 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 9 inclusion and 13 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 21 Jul 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?
area under the plasma concentration time curve from time zero to the last quantifiable time points (time frame: 48 hours). The study lists 12 primary outcomes in all. 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 21 Jul 2017.