Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pharmacokinetics Of Umeclidinium and Vilanterol in Healthy Chinese, a Randomized, Open Label, 3 Crossover Study.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01899638
Recruitment Status : Completed
First Posted : July 15, 2013
Last Update Posted : June 7, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief 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.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: UMEC/VI 125/25 mcg Drug: UMEC/VI 62.5/25 mcg Drug: UMEC 125 mcg Drug: UMEC 62.5 mcg Drug: VI 25 mcg Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : May 20, 2013
Actual Primary Completion Date : July 25, 2013
Actual Study Completion Date : July 25, 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: UMEC/VI 125/25 mcg
Combination in high dose
Drug: UMEC/VI 125/25 mcg
Combination in high dose

Experimental: UMEC/VI 62.5/25 mcg
Combination in low dose
Drug: UMEC/VI 62.5/25 mcg
Combination in low dose

Experimental: UMEC 125 mcg
LAMA mono in high dose
Drug: UMEC 125 mcg
LAMA mono in high dose

Experimental: UMEC 62.5 mcg
LAMA mono in low dose
Drug: UMEC 62.5 mcg
LAMA mono in low dose

Experimental: VI 25 mcg
LABA mono
Drug: VI 25 mcg
LABA mono




Primary Outcome Measures :
  1. Cmax [ Time Frame: 5 months ]
    For both single dose and repeat dose

  2. tmax [ Time Frame: 5 months ]
    For both single dose and repeat dose

  3. tlast [ Time Frame: 5 months ]
    For both single dose and repeat dose

  4. AUC0-t [ Time Frame: 5 months ]
    For both single dose and repeat dose

  5. t1/2 [ Time Frame: 5 months ]
    For both single dose and repeat dose

  6. CL/F [ Time Frame: 5 months ]
    For both single dose and repeat dose

  7. Vd/F [ Time Frame: 5 months ]
    For single dose

  8. AUC0-inf [ Time Frame: 5 months ]
    For single dose

  9. AUC0-t' [ Time Frame: 5 months ]
    For both single dose and repeat dose

  10. C τ [ Time Frame: 5 months ]
    For repeat dose

  11. AUC0-τ [ Time Frame: 5 months ]
    For repeat dose

  12. Ro [ Time Frame: 5 months ]
    For repeat dose

  13. RCmax [ Time Frame: 5 months ]
    For repeat dose

  14. DF [ Time Frame: 5 months ]
    For repeat dose


Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: 5 months ]
  2. Heart rate [ Time Frame: 5 months ]
  3. 12-lead ECG [ Time Frame: 5 months ]
  4. Chemistry [ Time Frame: 5 months ]
  5. Hematology [ Time Frame: 5 months ]
  6. Urinalysis [ Time Frame: 5 months ]
  7. Adverse event [ Time Frame: 5 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.
  • 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

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01899638


Locations
Layout table for location information
China
GSK Investigational Site
Shanghai, China, 200030
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Layout table for investigator information
Study Director: GSK Clinical Trials GlaxoSmithKline
Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 115380
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 115380
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 115380
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 115380
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 115380
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 115380
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 115380
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01899638    
Other Study ID Numbers: 115380
First Posted: July 15, 2013    Key Record Dates
Last Update Posted: June 7, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Additional relevant MeSH terms:
Layout table for MeSH terms
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive