ThrombocytopaeniaPhase 1NCT01657552
Eltrombopag/Boceprevir and Eltrombopag/Telaprevir Drug-Drug Interaction Study In Healthy Adult Subjects
A Phase 1 study testing Eltrombopag, Boceprevir and Telaprevir in people with Thrombocytopaenia, run by GlaxoSmithKline at 1 site in United States.
Trial summary
The purpose of the current Phase I, open-label, three-period, single sequence, crossover study, TPL116010, is to evaluate the potential drug-drug interaction between eltrombopag (ELT) and bocrprevir (BCP) and between ELT and telaprevir (TLP) in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Thrombocytopaenia
- What is being tested?
- Eltrombopag, Boceprevir and Telaprevir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2012to 26 Oct 2012
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects with no clinically significant abnormality identified by physician by evaluation of medical history, physical examination, clinical laboratory tests or electrocardiogram (ECG).
- Able to swallow and retain oral medication.
- Male or female subjects between the ages of 18 to 64 years of age inclusive, at the time of signing the informed consent.
- Capable of giving written informed consent which includes compliance with the requirements and restrictions listed in the consent form. Signed informed consent must be on file prior to screening procedures.
- Body weight >= 50 kilogram (kg) (110 pounds [lbs]) for men and >=45 kg (99 lbs) for women and body mass index (BMI) of 18.5 to 32.0 kg/ (meters squared) m^2 inclusive.
- Male subjects, who are not surgically sterile, must agree on abstinence or to use a double barrier method, such as, a condom plus spermicidal agent (foam/gel/film/cream/suppository). This criterion must be followed from the time of the first dose of study medication until 14 days after the last dose of medication.
- A female subject is eligible to participate if she is neither pregnant nor lactating, and falls into one of the following categories: non-childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy or bilateral oophorectomy, or postmenopausal females defined as being amenorrheic for greater than 1 year and having serum estradiol and follicle stimulating hormone levels consistent with menopause, child-bearing potential with negative beta human chorionic gonadotropin (βhCG) test and agrees to comply with recognized non-hormonal contraceptive methods from screening or at least two weeks prior to first dose (whichever is earlier) until the follow-up visit. Recognized non-hormonal contraceptive methods include: complete abstinence from intercourse, two forms of barrier contraception (e.g. condom with spermicide, or diaphragm with spermicide), or intrauterine device (IUD).
Who cannot join
- History of Gilbert's syndrome.
- History of deep vein thrombosis or other thromboembolic event.
- History of thrombocytopenia or bleeding due to abnormal platelet number or function.
- Clotting factor abnormalities associated with hypercoagulability, including Factor V Leiden, Protein C or Protein S deficiency or antithrombin III deficiency.
- Elevated blood pressure (BP) at screening, Day -1 and at pre-dose (systolic >140 mm Hg [millimeters of mercury], diastolic >90 mmHg). If the subject's BP is elevated on the first measurement, complete two additional BP measurements at least 2 minutes apart and average the three assessments to evaluate this criterion. If averaged BP exceeds the safety criteria, the subject should be excluded.
- History of atrial fibrillation, mitral valve prolapse, significant heart murmur or vascular bruit.
Show all 17Show fewer
- Prolonged QTcF interval at screening, Day 1 and at pre-dose (for females and males >450 milliseconds [ms]). If the QTcF interval is prolonged on the initial ECG, then complete two additional ECGs at least 5 minutes apart and take the average QTcF measurements of all three ECGs to evaluate this criterion. If averaged QTcF exceeds the safety criteria, the subject should be excluded.
- Female subjects currently receiving hormone replacement therapy (HRT).
- Positive for HIV, hepatitis B virus infection or HCV infection at screening.
- Positive urine drug screen including serum alcohol at screening or pre-dose (Day -1).
- History of alcohol/drug abuse or dependence within 12 months of the study. History of alcohol consumption in the past six months exceeding 7 units/week for women and 14 units/week for men (where 1 unit = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor).
- Urinary cotinine levels indicative of smoking at screening or pre-dose (Day -1). History of regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
- 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 aspirin and non-steroidal anti-inflammatory drugs [NSAIDs]), vitamins, herbal and dietary supplements within 7 days (or 14 days if the drug is a potential enzyme inducer, such as St. John's Wort) 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.
- Subjects who have donated plasma within 7 days prior to the screening visit or where participation in this study would result in donation of blood in excess of 500 milliliters (mL) within a 56-day period.
- History of sensitivity to any of the study medications, or components thereof.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-label, Three-Period, Single Sequence, Crossover Study Evaluating the Drug-Drug Interaction Between Eltrombopag and Boceprevir and Between Eltrombopag and Telaprevir in Healthy Adult Subjects
The purpose of the current Phase I, open-label, three-period, single sequence, crossover study, TPL116010, is to evaluate the potential drug-drug interaction between eltrombopag (ELT) and bocrprevir (BCP) and between ELT and telaprevir (TLP) in healthy subjects. In this study there will be a screening visit, three treatment periods, and a follow-up visit. In Period 1, subjects will receive a single dose of ELT on Day 1, and pharmacokinetic (PK) sampling will occur for 72 hours. In Period 2, subjects will receive BCP/TLP for 10 days with PK sampling for 8 hours. In Period 3, subjects will receive a single dose of ELT with BCP/TLP on Day 1 only with PK sampling for 72 hours. Subjects will return for a follow-up visit within 10 to 14 days of the last dose of study drugs. The total duration of the study from Screening to Follow-up will be approximately 9 weeks.
- Conditions
- Thrombocytopaenia
- Being tested
- Eltrombopag, Boceprevir, Telaprevir
- Keywords
- Drug interaction, INCIVEK (telaprevir),, SB-497115 (eltrombopag), Pharmacokinetics, Thrombocytopenia, VICTRELIS (boceprevir)
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EltrombopagDrug
Each tablet contains 100 mg of Eltrombopag (Dose 200 mg)
BoceprevirDrug
Each capsule contains 200 mg of Boceprevir (Dose 800 mg)
TelaprevirDrug
Each tablet contains 375 mg of Telaprevir (Dose 750 mg)
| Study group | Role | What they receive |
|---|---|---|
| Eltrombopag | Experimental | Subjects will receive single oral dose of eltrombopag 200 mg in Period 1 with moderate-fat, low-calcium meal. Receives: Drug: Eltrombopag |
| Boceprevir | Experimental | Subjects will receive boceprevir 800 mg orally every 8 hours (hrs) for 10 days in Period 2 with moderate-fat meals. Receives: Drug: Boceprevir |
| Telaprevir | Experimental | Subjects will receive telaprevir 750 mg orally every 8 hours hrs for 10 days in Period 2 with moderate-fat meals. Receives: Drug: Telaprevir |
| Eltrombopag and Broceprevir | Experimental | Subjects will receive eltrombopag 200 mg as single oral dose and boceprevir 800 mg orally every 8 hrs for a day in Period 3 with moderate-fat meals. Receives: Drug: Eltrombopag; Drug: Boceprevir |
| Eltrombopag and Telaprevir | Experimental | Subjects will receive eltrombopag 200 mg as single oral dose and telaprevir 750 mg orally every 8 hrs for a day in Period 3 with moderate-fat meals. Receives: Drug: Eltrombopag; Drug: Telaprevir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite pharmacokinetic (PK) parameters of eltrombopag following administration of boceprevir for 10 days with a single dose of eltrombopag
Plasma eltrombopag PK Parameters: area under the concentration time-curves from time zero to infinity AUC(0-infinity) and maximum concentration (Cmax).
Measured: For 17 days
Composite PK parameters of boceprevir following administration of boceprevir for 10 days with a single dose of eltrombopag
Plasma boceprevir PK Parameters: AUC from time zero to the dosing interval AUC(0-τ), Cmax, and Concentraction at end of the dosing interval (Cτ)
Measured: For 17 days
Composite PK parameters of eltrombopag following administration of telaprevir for 10 days with a single dose of eltrombopag
Plasma eltrombopag PK Parameters: AUC(0-infinity) and Cmax
Measured: For 17 days
Composite PK parameters of telaprevir following administration of telaprevir for 10 days with a single dose of eltrombopag
Plasma telaprevir PK Parameters: AUC(0-τ), Cmax, and Cτ.
Measured: For 17 days
Secondary outcomes (7)
Composite PK parameters of eltrombopag following administration of boceprevir for 10 days with a single dose of eltrombopag
Plasma eltrombopag PK Parameters: AUC from time zero to the last measurable concentration (AUC(0-t)), AUC obtained by extrapolation (%) (%AUCex), time from administration to first quantifiable concentration (tlag), time from administration to Cmax (tmax), elimination half life (t1/2), and apparent clearance (CL/F).
Measured: For 17 days
Composite PK parameters of boceprevir following administration of boceprevir for 10 days with a single dose of eltrombopag
Plasma boceprevir PK Parameter: tmax.
Measured: For 17 days
Composite PK parameters of eltrombopag following administration of telaprevir for 10 days with a single dose of eltrombopag
Plasma eltrombopag PK Parameters: AUC(0-t), %AUCex, tlag, tmax, t1/2, and CL/F.
Measured: For 17 days
Composite PK parameters of telaprevir following administration of telaprevir for 10 days with a single dose of eltrombopag
Plasma telaprevir PK Parameter: tmax.
Measured: For 17 days
Safety and tolerability as assessed by the collection of adverse events
Measured: For 28 days
Safety and tolerability as assessed by change from baseline in clinical laboratory tests
Clinical laboratory tests include hematology, clinical chemistry, urinalysis tests.
Measured: For 28 days
Safety and tolerability as assessed by change from baseline in vital sign
Vital sign measurements will include systolic and diastolic blood pressure and pulse rate.
Measured: For 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study start1 Aug 2012
- Primary completion26 Oct 2012
- Study completion26 Oct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombocytopaeniaStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 56 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
- NCT01657552
- Sponsor's protocol ID
- 116010
- Status last verified
- Nov 2017
- First submitted
- 2 Aug 2012
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Three-Period, Single Sequence, Crossover Study Evaluating the Drug-Drug Interaction Between Eltrombopag and Boceprevir and Between Eltrombopag and Telaprevir in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01657552
- Acronym / sponsor ID
- 116010
- Conditions
- Thrombocytopaenia
- Keywords
- Drug interaction, INCIVEK (telaprevir),, SB-497115 (eltrombopag), Pharmacokinetics, Thrombocytopenia, VICTRELIS (boceprevir)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2012 (actual)
- Primary completion
- 26 Oct 2012 (actual)
- Study completion
- 26 Oct 2012 (actual)
- First posted
- 6 Aug 2012 (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.
The purpose of the current Phase I, open-label, three-period, single sequence, crossover study, TPL116010, is to evaluate the potential drug-drug interaction between eltrombopag (ELT) and bocrprevir (BCP) and between ELT and telaprevir (TLP) in healthy subjects. In this study there will be a screening visit, three treatment periods, and a follow-up visit. In Period 1, subjects will receive a single dose of ELT on Day 1, and pharmacokinetic (PK) sampling will occur for 72 hours. In Period 2, subjects will receive BCP/TLP for 10 days with PK sampling for 8 hours. In Period 3, subjects will receive a single dose of ELT with BCP/TLP on Day 1 only with PK sampling for 72 hours. Subjects will return for a follow-up visit within 10 to 14 days of the last dose of study drugs. The total duration of the study from Screening to Follow-up will be approximately 9 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Eltrombopag | Experimental | Drug: EltrombopagSubjects will receive single oral dose of eltrombopag 200 mg in Period 1 with moderate-fat, low-calcium meal. |
| Boceprevir | Experimental | Drug: BoceprevirSubjects will receive boceprevir 800 mg orally every 8 hours (hrs) for 10 days in Period 2 with moderate-fat meals. |
| Telaprevir | Experimental | Drug: TelaprevirSubjects will receive telaprevir 750 mg orally every 8 hours hrs for 10 days in Period 2 with moderate-fat meals. |
| Eltrombopag and Broceprevir | Experimental | Drug: Eltrombopag, Drug: BoceprevirSubjects will receive eltrombopag 200 mg as single oral dose and boceprevir 800 mg orally every 8 hrs for a day in Period 3 with moderate-fat meals. |
| Eltrombopag and Telaprevir | Experimental | Drug: Eltrombopag, Drug: TelaprevirSubjects will receive eltrombopag 200 mg as single oral dose and telaprevir 750 mg orally every 8 hrs for a day in Period 3 with moderate-fat meals. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy subjects with no clinically significant abnormality identified by physician by evaluation of medical history, physical examination, clinical laboratory tests or electrocardiogram (ECG).
- Able to swallow and retain oral medication.
- Male or female subjects between the ages of 18 to 64 years of age inclusive, at the time of signing the informed consent.
- Capable of giving written informed consent which includes compliance with the requirements and restrictions listed in the consent form. Signed informed consent must be on file prior to screening procedures.
- Body weight >= 50 kilogram (kg) (110 pounds [lbs]) for men and >=45 kg (99 lbs) for women and body mass index (BMI) of 18.5 to 32.0 kg/ (meters squared) m^2 inclusive.
Key exclusion criteria (17 listed)
- History of Gilbert's syndrome.
- History of deep vein thrombosis or other thromboembolic event.
- History of thrombocytopenia or bleeding due to abnormal platelet number or function.
- Clotting factor abnormalities associated with hypercoagulability, including Factor V Leiden, Protein C or Protein S deficiency or antithrombin III deficiency.
- Elevated blood pressure (BP) at screening, Day -1 and at pre-dose (systolic >140 mm Hg [millimeters of mercury], diastolic >90 mmHg). If the subject's BP is elevated on the first measurement, complete two additional BP measurements at least 2 minutes apart and average the three assessments to evaluate this criterion. If averaged BP exceeds the safety criteria, the subject should be excluded.
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 |
|---|---|---|
| EltrombopagEach tablet contains 100 mg of Eltrombopag (Dose 200 mg) | Drug | Eltrombopag, Eltrombopag and Broceprevir, Eltrombopag and Telaprevir |
| BoceprevirEach capsule contains 200 mg of Boceprevir (Dose 800 mg) | Drug | Boceprevir, Eltrombopag and Broceprevir |
| TelaprevirEach tablet contains 375 mg of Telaprevir (Dose 750 mg) | Drug | Eltrombopag and Telaprevir, Telaprevir |
Primary outcome
Composite pharmacokinetic (PK) parameters of eltrombopag following administration of boceprevir for 10 days with a single dose of eltrombopag
Time frame: For 17 days
Plasma eltrombopag PK Parameters: area under the concentration time-curves from time zero to infinity AUC(0-infinity) and maximum concentration (Cmax).
Composite PK parameters of boceprevir following administration of boceprevir for 10 days with a single dose of eltrombopag
Time frame: For 17 days
Plasma boceprevir PK Parameters: AUC from time zero to the dosing interval AUC(0-τ), Cmax, and Concentraction at end of the dosing interval (Cτ)
Composite PK parameters of eltrombopag following administration of telaprevir for 10 days with a single dose of eltrombopag
Time frame: For 17 days
Plasma eltrombopag PK Parameters: AUC(0-infinity) and Cmax
Composite PK parameters of telaprevir following administration of telaprevir for 10 days with a single dose of eltrombopag
Time frame: For 17 days
Plasma telaprevir PK Parameters: AUC(0-τ), Cmax, and Cτ.
7 secondary outcomes
Composite PK parameters of eltrombopag following administration of boceprevir for 10 days with a single dose of eltrombopag
Time frame: For 17 days
Composite PK parameters of boceprevir following administration of boceprevir for 10 days with a single dose of eltrombopag
Time frame: For 17 days
Composite PK parameters of eltrombopag following administration of telaprevir for 10 days with a single dose of eltrombopag
Time frame: For 17 days
Composite PK parameters of telaprevir following administration of telaprevir for 10 days with a single dose of eltrombopag
Time frame: For 17 days
Safety and tolerability as assessed by the collection of adverse events
Time frame: For 28 days
Safety and tolerability as assessed by change from baseline in clinical laboratory tests
Time frame: For 28 days
Safety and tolerability as assessed by change from baseline in vital sign
Time frame: For 28 days
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 13 Nov 2017.
- Results for study 116010 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 Eltrombopag, Boceprevir and Telaprevir in people with Thrombocytopaenia, 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 7 inclusion and 17 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 13 Nov 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?
Composite pharmacokinetic (PK) parameters of eltrombopag following administration of boceprevir for 10 days with a single dose of eltrombopag (time frame: For 17 days). The study lists 4 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 13 Nov 2017.