Study to Assess the Safety and PK of GSK573719 and GSK573719/GW642444(VI) Combination in Healthy Subjects and Subjects With Severe Renal Impairment
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ClinicalTrials.gov Identifier: NCT01571999 |
Recruitment Status
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Completed
First Posted
: April 5, 2012
Last Update Posted
: July 25, 2017
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Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
Tracking Information | |||||||
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First Submitted Date ICMJE | April 3, 2012 | ||||||
First Posted Date ICMJE | April 5, 2012 | ||||||
Last Update Posted Date | July 25, 2017 | ||||||
Actual Study Start Date ICMJE | March 29, 2012 | ||||||
Actual Primary Completion Date | June 22, 2012 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
GSK573719 and vilanterol plasma pharmacokinetic parameters [ Time Frame: Treatment Period 1 and 2: pre-dose, 5 mins, 15 mins, 30 mins, 1hr, 2hrs, 4hrs, 8hrs, 12hrs, 16hrs, 24hrs ] Including AUC(0-t), AUC(0-t'), Cmax, tmax, AUC(0-24), AUC(0-infinity), tlast, t1/2
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Original Primary Outcome Measures ICMJE |
GSK573719 and vilanterol plasma pharmacokinetic parameters [ Time Frame: Treatment Period 1 & 2: pre-dose, 5 mins, 15 mins, 30 mins, 1hr, 2hrs, 4hrs, 8hrs, 12hrs, 16hrs, 24hrs ] Including AUC(0-t), AUC(0-t'), Cmax, tmax, AUC(0-24), AUC(0-infinity), tlast, t1/2
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Change History | Complete list of historical versions of study NCT01571999 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | ||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Study to Assess the Safety and PK of GSK573719 and GSK573719/GW642444(VI) Combination in Healthy Subjects and Subjects With Severe Renal Impairment | ||||||
Official Title ICMJE | A Single-blind, Non-randomized Pharmacokinetic and Safety Study of Single Dose of GSK573719 and GSK573719 + GW642444 Combination in Healthy Subjects and in Subjects With Severe Renal Impairment | ||||||
Brief Summary | This study will assess the safety and pharmacokinetics of inhaled GSK573719 and GSK573719/vilanterol combination in healthy subjects and in subjects with severe renal impairment. The results of the study will provide guidance on the use of this product in subjects with severe renal impairment. | ||||||
Detailed Description | GSK573719 monotherapy and GSK573719/vilanterol combination are currently under development for the treatment of COPD. This study will assess the pharmacokinetics and safety of inhaled GSK573719 and GSK573719/vilanterol (VI) in healthy subjects and in subjects with severe renal impairment. Nine subjects with severe renal impairment (as defined by a Clcr<30mL/min) will be recruited along with healthy control subjects (as defined by a Clcr>80mL/min matched to the severe renal impairment subjects based on gender, ethnicity, body mass index (±15%) and age (±5 years)). The results from this study will provide guidance on the use of GSK573719 and GSK573719/VI in severe renally impaired patients. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase | Phase 1 | ||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Crossover Assignment Masking: Single (Participant) Primary Purpose: Basic Science |
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Condition ICMJE | Pulmonary Disease, Chronic Obstructive | ||||||
Intervention ICMJE |
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Study Arms |
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Publications * | Mehta R, Hardes K, Brealey N, Tombs L, Preece A, Kelleher D. Effect of severe renal impairment on umeclidinium and umeclidinium/vilanterol pharmacokinetics and safety: a single-blind, nonrandomized study. Int J Chron Obstruct Pulmon Dis. 2014 Dec 18;10:15-23. doi: 10.2147/COPD.S68094. eCollection 2015. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
17 | ||||||
Original Estimated Enrollment ICMJE |
18 | ||||||
Actual Study Completion Date | June 22, 2012 | ||||||
Actual Primary Completion Date | June 22, 2012 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea or, child-bearing potential and is abstinent or agrees to use one of the contraception methods listed in the protocol for an appropriate period of time prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until follow-up.
Healthy Subjects:
Renally Impaired subjects:
Exclusion Criteria:
Healthy Subjects:
Renally Impaired Subjects:
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Sex/Gender |
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Ages | 18 Years to 70 Years (Adult, Senior) | ||||||
Accepts Healthy Volunteers | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Czechia, Hungary | ||||||
Removed Location Countries | Czech Republic | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01571999 | ||||||
Other Study ID Numbers ICMJE | 114636 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement |
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Responsible Party | GlaxoSmithKline | ||||||
Study Sponsor ICMJE | GlaxoSmithKline | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | GlaxoSmithKline | ||||||
Verification Date | July 2017 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |