Pulmonary Disease, Chronic ObstructivePhase 1NCT01899638
Pharmacokinetics Of Umeclidinium and Vilanterol in Healthy Chinese, a Randomized, Open Label, 3 Crossover Study.
A Phase 1 study testing UMEC/VI 125/25 mcg, UMEC/VI 62.5/25 mcg and UMEC 125 mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in China.
Trial summary
This study is to assess the pharmacokinetics (PK), safety and tolerability of UMEC (62.5µg and 125µg) and VI (25µg) as monotherapies and combinations in healthy Chinese subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- UMEC/VI 125/25 mcg, UMEC/VI 62.5/25 mcg and UMEC 125 mcg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2013to 25 Jul 2013
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or females at ratio of 1:1, aged 18 - 45 years . Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- Body weight ≥ 50kg and body mass index (weight/height2) within the range of 19 - 24 kg/m2, inclusive.
- Male or female subjects at the time of signing the informed consent:
- Female subject who is child-bearing potential should agree to use one of the contraception methods (contraceptives intrauterine device, implantable progesterone device or oral contraceptive) for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. The subjects must agree to use contraception until completion of the follow-up visit.
- Male subjects have to agree to use one of the contraception methods listed in Section 8.1.2. This criterion is to be followed from the time of the first dose of study medication until completion of the follow-up visit
- Normal systolic (90-139mmHg) and diastolic (60-89mmHg) blood pressure at pre-study screening.
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- Subjects who are current non-smokers, who have not used any tobacco products in the 6 month period preceding the screening visit, and have a pack history of 10 pack years. (pack years = (cigarettes per day smoked/20) × number of years smoked)).
- No significant abnormality on 12-lead ECG at screening, QTcF interval must be <450msec (QTcF; machine or manual reading).
- AST (SGOT), ALT (SGPT), and total-bilirubin 1.5xULN at screening. No significant clinical abnormality on other laboratory tests.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Subjects who are able to use the inhalation device satisfactorily
Who cannot join
- As a result of medical interview, physical examination or screening investigations, the principle investigator or delegate physician deems the subject unsuitable for the study.
- History of mental, cardiac, renal, hepatic, significant gastrointestinal or respiratory disease as judged by the investigator
- A history of breathing problems (i.e. history of asthmatic symptomatology, unless asthma in childhood that has now resolved and no longer requires maintenance therapy which should not be an exclusion).
- A chest X-ray or computed tomography (CT) scan that reveals evidence of clinically significant abnormalities. A chest X-ray must be taken at day -1 of the first treatment if a chest X-ray or CT scan is not available within 6 months prior to that day.
- History of sensitivity to heparin, heparin-induced thrombocytopenia, or sensitivity to any of the study medications, or components thereof, known allergy or hypersensitivity to milk protein or the excipients lactose monohydrate and magnesium stearate (MgSt), or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- The subject has taken prescription or non-prescription drugs, including CYP3A/PGP inhibitor, 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.
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- Positive result of urine cotinine test.
- The subject has a history of cholecystectomy or biliary tract disease.
- The subject has a significant clinical history or current conditions of glaucoma.
- The subject has a significant clinical history or current conditions of prostatic hypertrophy.
- The subject has a positive pre-study drug screen. A minimum list of drugs that were screened for included amphetamines, barbiturates, cocaine, opiates and benzodiazepines. The detection of drugs with a legitimate medical use was not necessarily an exclusion to study participation. The detection of alcohol was not an exclusion at screening but had to be negative pre-dose and during the study.
- History of regular alcohol consumption within 3 months of the study defined as:
- Abuse of an average weekly intake of greater than 21 units or an average daily intake of greater than three units (males), or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than two units (females). One unit was equivalent to a half-pint (220 mL) of beer or one (25 mL) measure of spirits or one glass (125 mL) of wine.
- Female subjects, who are pregnant, planned pregnancy or lactation.
- 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).
- Blood donation or sampled as a study subject within three months preceding the first dose of study drug and blood donation during the entire study in excess of 500mL.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- The subject has tested positive for HIV antibodies.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subject is mentally or legally incapacitated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label, 3 Crossover, Balanced Incomplete Block Study To Evaluate The Pharmacokinetics Of Umeclidinium Bromide and Vilanterol Trifenatate as Monotherapies and Concurrently in Healthy Chinese Subjects.
This study is to assess the pharmacokinetics (PK), safety and tolerability of UMEC (62.5µg and 125µg) and VI (25µg) as monotherapies and combinations in healthy Chinese subjects.
Read the detailed description
Vilanterol trifenatate (VI) is a potent and selective long-acting β2 agonist; Umeclidinium bromide (UMEC) is a long-acting, inhaled, muscarinic receptor antagonist (LAMA). Both compounds are in development once daily for the treatment of Chronic Obstructive Pulmonary Disease (COPD).
This study is a randomized, open label, three-period crossover, balanced incomplete block study which will assess the pharmacokinetics (PK), safety and tolerability of UMEC (62.5µg and 125µg) and VI (25µg) as monotherapies and combinations in 20 healthy Chinese subjects. Each subject will receive three of five possible treatments for 10 days each.
Blood samples for PK analysis will be taken at designed timepoints. Safety will be assessed by measurement of ECG QTcF, heart rate, blood pressure, and safety laboratory data and review of adverse events.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- UMEC/VI 125/25 mcg, UMEC/VI 62.5/25 mcg, UMEC 125 mcg, UMEC 62.5 mcg, VI 25 mcg
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UMEC/VI 125/25 mcgDrug
Combination in high dose
UMEC/VI 62.5/25 mcgDrug
Combination in low dose
UMEC 125 mcgDrug
LAMA mono in high dose
UMEC 62.5 mcgDrug
LAMA mono in low dose
VI 25 mcgDrug
LABA mono
| Study group | Role | What they receive |
|---|---|---|
| UMEC/VI 125/25 mcg | Experimental | Combination in high dose Receives: Drug: UMEC/VI 125/25 mcg |
| UMEC/VI 62.5/25 mcg | Experimental | Combination in low dose Receives: Drug: UMEC/VI 62.5/25 mcg |
| UMEC 125 mcg | Experimental | LAMA mono in high dose Receives: Drug: UMEC 125 mcg |
| UMEC 62.5 mcg | Experimental | LAMA mono in low dose Receives: Drug: UMEC 62.5 mcg |
| VI 25 mcg | Experimental | LABA mono Receives: Drug: VI 25 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
For both single dose and repeat dose
Measured: 5 months
tmax
For both single dose and repeat dose
Measured: 5 months
tlast
For both single dose and repeat dose
Measured: 5 months
AUC0-t
For both single dose and repeat dose
Measured: 5 months
t1/2
For both single dose and repeat dose
Measured: 5 months
CL/F
For both single dose and repeat dose
Measured: 5 months
Vd/F
For single dose
Measured: 5 months
AUC0-inf
For single dose
Measured: 5 months
AUC0-t'
For both single dose and repeat dose
Measured: 5 months
C τ
For repeat dose
Measured: 5 months
AUC0-τ
For repeat dose
Measured: 5 months
Ro
For repeat dose
Measured: 5 months
RCmax
For repeat dose
Measured: 5 months
DF
For repeat dose
Measured: 5 months
Secondary outcomes (7)
Blood pressure
Measured: 5 months
Heart rate
Measured: 5 months
12-lead ECG
Measured: 5 months
Chemistry
Measured: 5 months
Hematology
Measured: 5 months
Urinalysis
Measured: 5 months
Adverse event
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2013 (estimated)
- Study start20 May 2013
- Primary completion25 Jul 2013
- Study completion25 Jul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- 20 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
- NCT01899638
- Sponsor's protocol ID
- 115380
- Status last verified
- Jun 2017
- First submitted
- 30 May 2013
- Last updated
- 7 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Hu C, Jia J, Dong K, Luo L, Wu K, Mehta R, Peng J, Ren Y, Gross A, Yu H. Pharmacokinetics and tolerability of inhaled umeclidinium and vilanterol alone and in combination in healthy Chinese subjects: a randomized, open-label, crossover trial. PLoS One. 2015 Mar 27;10(3):e0121264. doi: 10.1371/journal.pone.0121264. eCollection 2015.
PubMed 25816315
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, 3 Crossover, Balanced Incomplete Block Study To Evaluate The Pharmacokinetics Of Umeclidinium Bromide and Vilanterol Trifenatate as Monotherapies and Concurrently in Healthy Chinese Subjects.
- ClinicalTrials.gov ID
- NCT01899638
- Acronym / sponsor ID
- 115380
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 20 May 2013 (actual)
- Primary completion
- 25 Jul 2013 (actual)
- Study completion
- 25 Jul 2013 (actual)
- First posted
- 15 Jul 2013 (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 to assess the pharmacokinetics (PK), safety and tolerability of UMEC (62.5µg and 125µg) and VI (25µg) as monotherapies and combinations in healthy Chinese subjects.
Detailed description
Vilanterol trifenatate (VI) is a potent and selective long-acting β2 agonist; Umeclidinium bromide (UMEC) is a long-acting, inhaled, muscarinic receptor antagonist (LAMA). Both compounds are in development once daily for the treatment of Chronic Obstructive Pulmonary Disease (COPD).
This study is a randomized, open label, three-period crossover, balanced incomplete block study which will assess the pharmacokinetics (PK), safety and tolerability of UMEC (62.5µg and 125µg) and VI (25µg) as monotherapies and combinations in 20 healthy Chinese subjects. Each subject will receive three of five possible treatments for 10 days each.
Blood samples for PK analysis will be taken at designed timepoints. Safety will be assessed by measurement of ECG QTcF, heart rate, blood pressure, and safety laboratory data and review of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| UMEC/VI 125/25 mcg | Experimental | Drug: UMEC/VI 125/25 mcgCombination in high dose |
| UMEC/VI 62.5/25 mcg | Experimental | Drug: UMEC/VI 62.5/25 mcgCombination in low dose |
| UMEC 125 mcg | Experimental | Drug: UMEC 125 mcgLAMA mono in high dose |
| UMEC 62.5 mcg | Experimental | Drug: UMEC 62.5 mcgLAMA mono in low dose |
| VI 25 mcg | Experimental | Drug: VI 25 mcgLABA mono |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy male or females at ratio of 1:1, aged 18 - 45 years . Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- Body weight ≥ 50kg and body mass index (weight/height2) within the range of 19 - 24 kg/m2, inclusive.
- Male or female subjects at the time of signing the informed consent:
- Female subject who is child-bearing potential should agree to use one of the contraception methods (contraceptives intrauterine device, implantable progesterone device or oral contraceptive) for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. The subjects must agree to use contraception until completion of the follow-up visit.
- Male subjects have to agree to use one of the contraception methods listed in Section 8.1.2. This criterion is to be followed from the time of the first dose of study medication until completion of the follow-up visit
Key exclusion criteria (20 listed)
- As a result of medical interview, physical examination or screening investigations, the principle investigator or delegate physician deems the subject unsuitable for the study.
- History of mental, cardiac, renal, hepatic, significant gastrointestinal or respiratory disease as judged by the investigator
- A history of breathing problems (i.e. history of asthmatic symptomatology, unless asthma in childhood that has now resolved and no longer requires maintenance therapy which should not be an exclusion).
- A chest X-ray or computed tomography (CT) scan that reveals evidence of clinically significant abnormalities. A chest X-ray must be taken at day -1 of the first treatment if a chest X-ray or CT scan is not available within 6 months prior to that day.
- History of sensitivity to heparin, heparin-induced thrombocytopenia, or sensitivity to any of the study medications, or components thereof, known allergy or hypersensitivity to milk protein or the excipients lactose monohydrate and magnesium stearate (MgSt), or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
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 |
|---|---|---|
| UMEC/VI 125/25 mcgCombination in high dose | Drug | UMEC/VI 125/25 mcg |
| UMEC/VI 62.5/25 mcgCombination in low dose | Drug | UMEC/VI 62.5/25 mcg |
| UMEC 125 mcgLAMA mono in high dose | Drug | UMEC 125 mcg |
| UMEC 62.5 mcgLAMA mono in low dose | Drug | UMEC 62.5 mcg |
| VI 25 mcgLABA mono | Drug | VI 25 mcg |
Primary outcome
Cmax
Time frame: 5 months
For both single dose and repeat dose
tmax
Time frame: 5 months
For both single dose and repeat dose
tlast
Time frame: 5 months
For both single dose and repeat dose
AUC0-t
Time frame: 5 months
For both single dose and repeat dose
t1/2
Time frame: 5 months
For both single dose and repeat dose
CL/F
Time frame: 5 months
For both single dose and repeat dose
Vd/F
Time frame: 5 months
For single dose
AUC0-inf
Time frame: 5 months
For single dose
AUC0-t'
Time frame: 5 months
For both single dose and repeat dose
C τ
Time frame: 5 months
For repeat dose
AUC0-τ
Time frame: 5 months
For repeat dose
Ro
Time frame: 5 months
For repeat dose
RCmax
Time frame: 5 months
For repeat dose
DF
Time frame: 5 months
For repeat dose
7 secondary outcomes
Blood pressure
Time frame: 5 months
Heart rate
Time frame: 5 months
12-lead ECG
Time frame: 5 months
Chemistry
Time frame: 5 months
Hematology
Time frame: 5 months
Urinalysis
Time frame: 5 months
Adverse event
Time frame: 5 months
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 7 Jun 2017.
- Derived from this study: PubMed 25816315Hu C, Jia J, Dong K, Luo L, Wu K, Mehta R, Peng J, Ren Y, Gross A, Yu H. Pharmacokinetics and tolerability of inhaled umeclidinium and vilanterol alone and in combination in healthy Chinese subjects: a randomized, open-label, crossover trial. PLoS One. 2015 Mar 27;10(3):e0121264. doi: 10.1371/journal.pone.0121264. eCollection 2015.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Results for study 115380 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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 UMEC/VI 125/25 mcg, UMEC/VI 62.5/25 mcg and UMEC 125 mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in China.
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 20 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 7 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 China. 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 (time frame: 5 months). The study lists 14 primary outcomes in all. 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 NCT01899638, which also lists 1 linked publication.
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 7 Jun 2017.