HyperhidrosisPhase 1NCT01934153
Characterization of Exposure From Topical Administration of [14C] Umeclidinium to Axilla or Palm of Healthy Male Subjects
A Phase 1 study testing [14C]Umeclidinium 18.5 mg in people with Hyperhidrosis, run by GlaxoSmithKline at 1 site in Netherlands.
Trial summary
The purpose of this study is to characterize the pharmacokinetics (PK), safety and tolerability of topically applied umeclidinium following single dose topical administration. The results from this study will be used to 1) improve our understanding of the risk of systemic accumulation upon chronic administration, 2)… Read more about this study
- Who is it for?
- Ages 30 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperhidrosis
- What is being tested?
- [14C]Umeclidinium 18.5 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Sep 2013to 19 Feb 2014
- 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 30 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring (including screening ECG and screening Holter 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 considers the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. Subjects with significant lab values outside the normal range should always be excluded from enrolment.
- The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions and is likely to complete the study as planned. Subject is willing to provide informed consent.
- Axilla or palm size must be able to accommodate one of the 40 centimeter square (cm^2) templates and, as relevant for the cohort, the protective device.
- Axilla or palm must be free of tattoos, scar tissue or other tissue damage that could affect drug absorption or subject safety.
- Males between 30 and 55 years of age inclusive, at the time of signing the informed consent.
- Body Mass Index (BMI) within the range 18-27 kilogram per meter square (kg/m^2) (inclusive).
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- 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.
- Alanine aminotransferase (ALT), alkaline phosphatase (ALP) and bilirubin <=1.5xupper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Corrected QT interval using Fridericia formula (QTcF) <450 msec; or QTcF <480 milliseconds (msec) in subjects with Bundle Branch Block
Who cannot join
- Subject is mentally or legally incapacitated.
- History of current significant medical illness including cardiovascular thrombotic events, myocardial infarction, stroke or other cardiac disease, hypertension, peptic ulcer disease or gastrointestinal bleeding, skin disorders, hematological disease, bronchospastic respiratory disease, asthma, diabetes mellitus, renal or hepatic insufficiency, or any other illness that the investigator deems clinically significant for exclusion of the subject from the study.
- Diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the opinion of the study investigator or GSK medical monitor would prevent use of an anticholinergic and therefore study participation.
- A mean QTcF value at screening >450msec, the QTcF of all 3 screening ECGs are not within 10% of the mean, or an ECG that is not suitable for QT measurements (e.g. poorly defined termination of the T wave).
- A history of elevated resting blood pressure or a mean blood pressure equal to or higher than 139/89 millimeters of mercury (mmHg) at screening or prior to dosing.
- A mean heart rate outside the range 40-100 beats per minute (bpm) at screening or prior to dosing.
Show all 24Show fewer
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other significant allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Unable or unwilling to avoid use of under-arm deodorant or topical creams/lotions etc. to axilla or palms (depending on the subject's cohort) from admission on Day -1 until discharged from the unit (note washing with soap and water will be permitted on a daily basis once the topical agent has been removed from the application site).
- The radiation exposure from the previous 3 year period is over 10 millisievert (mSv) for any subject who has been exposed to ionizing radiation above background levels as a result of his work with radiation as a Category A (classified) worker or as a result of research studies in which he may have been involved.
- An occupation which requires monitoring for radiation exposure, nuclear medicine procedures or excessive x-rays within the past 12 months.
- Participation in a clinical trial involving administration of 14C-labelled compound(s) within the last 12 months. Each subject's previous effective dose will be reviewed by the medical investigator to ensure there is no risk of contamination / carryover into the current study.
- Subjects who have received a total body radiation dose of greater than 0.7 mSv or exposure to significant radiation (e.g. computed tomography [CT] scan) for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton (excluding spinal column) during work or during participation in a medical trial in the previous year.
- 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: 60 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- A positive pre-study drug/alcohol screen.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- A positive test for Human Immunodeficiency Virus (HIV) antibody.
- History of smoking >= 5 cigarettes/day within the last year and any smoker who is unwilling or unable to refrain from smoking while participating in the clinical trial.
- History of regular alcohol consumption within 6 months of the study.
- Unable to refrain from consumption of red wine, Seville oranges, kumquat, satsuma, ugli, tangerine, tangelo, sprite, cassis, grapefruit or grapefruit juice and/or pummelos, other citrus fruits, grapefruit hybrids or fruit juices containing such products from 7 days prior to the first dose of study medication.
- Unable to refrain from the 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 (if available, 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.
- Where participation in the study would result in donation of blood or blood products in excess of 500 milliliter (mL) within a 60 day period.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to characterize the pharmacokinetics (PK), safety and tolerability of topically applied umeclidinium following single dose topical administration. The results from this study will be used to 1) improve our understanding of the risk of systemic accumulation upon chronic administration, 2) support dosing recommendations in a 2a/2b study for axillary administration and, potentially, a separate combined 2a/2b study for palmar administration, and 3) confirm whether the same formulation can be used for axillary and palmar application for the next studies.
- Conditions
- Hyperhidrosis
- Being tested
- [14C]Umeclidinium 18.5 mg
- Keywords
- hyperhidrosis, topical, [14C] radiolabel, palm, GSK573719, axilla, Umeclidinium
- Medical subject headings
- Hyperhidrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]Umeclidinium 18.5 mgDrug
Umeclidinium will be supplied as clear, colorless solution, free from visible particulates, single dose, topical solution in clear glass jars. Dosage of 18.5 mg of Umeclidinium per gram is equivalent to 22 mg per gram of the bromide salt.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Single dose of topical [14C]Umeclidinium was applied to the unoccluded axilla, and the drug which will be applied to the test site has to remain on the application site for 8 hrs Receives: Drug: [14C]Umeclidinium 18.5 mg |
| Cohort B | Experimental | Single dose of topical [14C]Umeclidinium was applied to the occluded axilla, and the drug which will be applied to the test site has remain on the application site for 8 hrs Receives: Drug: [14C]Umeclidinium 18.5 mg |
| Cohort C | Experimental | Single dose of topical [14C]Umeclidinium was applied to the unoccluded palm, and the drug which will be applied to the test site has to remain on the application site for 8 hrs Receives: Drug: [14C]Umeclidinium 18.5 mg |
| Cohort D | Experimental | Single dose of topical [14C]Umeclidinium was applied to the occluded palm, and the drug which will be applied to the test site has to remain on the application site for 8 hrs Receives: Drug: [14C]Umeclidinium 18.5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK Assessment (Cmax) for [14C] umeclidinium and total radioactivity
Blood sample will be collected for PK assessment including maximum observed plasma concentration (Cmax).
Measured: Day 1: Predose, 2, 4, 5, 6, 8, 8.5, 9, 9.5, 10, 11, 12, 13, 14 and 16 hrs postdose. Day 2: 24, 30 and 36 hrs. Day 3 (48 hours), Day 4 (72 hrs) and up to follow-up Day 14.
PK Assessment (tmax) for [14C] umeclidinium and total radioactivity
Blood sample will be collected for PK assessment including time to Cmax (tmax).
Measured: Day 1: Predose, 2, 4, 5, 6, 8, 8.5, 9, 9.5, 10, 11, 12, 13, 14 and 16 hrs postdose. Day 2: 24, 30 and 36 hrs. Day 3 (48 hours), Day 4 (72 hrs) and up to follow-up Day 14.
PK Assessment (AUC) for [14C] umeclidinium and total radioactivity
Blood sample will be collected for PK assessment including area under the plasma concentration-time curve (AUC) from time 0 to the last quantifiable sample (AUC0-last), AUC from time zero to 12 hrs or 24 hrs (AUC0-12 and AUC0-24, respectively), AUC from time zero to time infinity [AUC (0-infinity)].
Measured: Day 1: Predose, 2, 4, 5, 6, 8, 8.5, 9, 9.5, 10, 11, 12, 13, 14 and 16 hrs postdose. Day 2: 24, 30 and 36 hrs. Day 3 (48 hours), Day 4 (72 hrs) and up to follow-up Day 14.
PK Assessment (t1/2) for [14C] umeclidinium and total radioactivity
Blood sample will be collected for PK assessment including apparent terminal phase half-life (t1/2).
Measured: Day 1: Predose, 2, 4, 5, 6, 8, 8.5, 9, 9.5, 10, 11, 12, 13, 14 and 16 hrs postdose. Day 2: 24, 30 and 36 hrs. Day 3 (48 hours), Day 4 (72 hrs) and up to follow-up Day 14.
Compartmental modeling of absorption rate for [14C] umeclidinium
Compartmental modeling may be conducted to characterize the absorption rate constants.
Measured: Day 1: Predose, 2, 4, 5, 6, 8, 8.5, 9, 9.5, 10, 11, 12, 13, 14 and 16 hrs postdose. Day 2: 24, 30 and 36 hrs. Day 3 (48 hours), Day 4 (72 hrs) and up to follow-up Day 14.
Compartmental modeling of elimination rate for [14C] umeclidinium
Compartmental modeling may be conducted to characterize the elimination rate constants.
Measured: Day 1: Predose, 2, 4, 5, 6, 8, 8.5, 9, 9.5, 10, 11, 12, 13, 14 and 16 hrs postdose. Day 2: 24, 30 and 36 hrs. Day 3 (48 hours), Day 4 (72 hrs) and up to follow-up Day 14.
Secondary outcomes (8)
Determine the amount of Umeclidinium absorbed in the skin
Evaluations will be determined by subtracting the amount of drug recovered from skin and tape strips
Measured: Day 1 (and Day 2 if required)
Safety Assessment for AEs
Safety evaluations will be based on the incidence, intensity and type of adverse events (AEs)
Measured: From first dose up to Follow-up (Day 14)
Safety Assessment for ECGs, and telemetry
Safety evaluations will be based on the 12-lead electrocardiograms (ECGs) and Lead II ECG monitoring.
Measured: From Screening up to Follow-up (Day 14)
Safety Assessment for hematology laboratory parameters
Safety evaluations will be based on hematology laboratory results
Measured: From Screening up to Follow-up (Day 14)
Safety Assessment for measurement of blood pressure
Safety evaluations will be based on the clinically significant changes in vital signs includes systolic and diastolic blood pressure
Measured: From Screening up to Follow-up (Day 14)
Number of subjects with application site skin irritation
Safety evaluations will be based on application site skin irritation. The number of subjects with application site skin irritation (as measured by the Skin Tolerability Assessment Scale) will be summarized.
Measured: From Day 1 up to Follow-up (Day 14)
Safety Assessment for clinical chemistry laboratory parameters
Safety evaluations will be based on the clinical chemistry laboratory results
Measured: From Screening up to Follow-up (Day 14)
Safety Assessment for measurement of pulse rate
Safety evaluations will be based on the clinically significant changes in vital signs includes pulse rate
Measured: From Screening up to Follow-up (Day 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2013 (estimated)
- Study start2 Sep 2013
- Primary completion19 Feb 2014
- Study completion19 Feb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperhidrosisStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT01934153
- Sponsor's protocol ID
- 117157
- Status last verified
- May 2017
- First submitted
- 15 Aug 2013
- Last updated
- 15 May 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Exposure From Topical Administration of [14C] Umeclidinium to Axilla or Palm of Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01934153
- Acronym / sponsor ID
- 117157
- Conditions
- Hyperhidrosis
- Keywords
- hyperhidrosis, topical, [14C] radiolabel, palm, GSK573719, axilla, Umeclidinium
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 2 Sep 2013 (actual)
- Primary completion
- 19 Feb 2014 (actual)
- Study completion
- 19 Feb 2014 (actual)
- First posted
- 4 Sep 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.
The purpose of this study is to characterize the pharmacokinetics (PK), safety and tolerability of topically applied umeclidinium following single dose topical administration. The results from this study will be used to 1) improve our understanding of the risk of systemic accumulation upon chronic administration, 2) support dosing recommendations in a 2a/2b study for axillary administration and, potentially, a separate combined 2a/2b study for palmar administration, and 3) confirm whether the same formulation can be used for axillary and palmar application for the next studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: [14C]Umeclidinium 18.5 mgSingle dose of topical [14C]Umeclidinium was applied to the unoccluded axilla, and the drug which will be applied to the test site has to remain on the application site for 8 hrs |
| Cohort B | Experimental | Drug: [14C]Umeclidinium 18.5 mgSingle dose of topical [14C]Umeclidinium was applied to the occluded axilla, and the drug which will be applied to the test site has remain on the application site for 8 hrs |
| Cohort C | Experimental | Drug: [14C]Umeclidinium 18.5 mgSingle dose of topical [14C]Umeclidinium was applied to the unoccluded palm, and the drug which will be applied to the test site has to remain on the application site for 8 hrs |
| Cohort D | Experimental | Drug: [14C]Umeclidinium 18.5 mgSingle dose of topical [14C]Umeclidinium was applied to the occluded palm, and the drug which will be applied to the test site has to remain on the application site for 8 hrs |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring (including screening ECG and screening Holter 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 considers the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. Subjects with significant lab values outside the normal range should always be excluded from enrolment.
- The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions and is likely to complete the study as planned. Subject is willing to provide informed consent.
- Axilla or palm size must be able to accommodate one of the 40 centimeter square (cm^2) templates and, as relevant for the cohort, the protective device.
- Axilla or palm must be free of tattoos, scar tissue or other tissue damage that could affect drug absorption or subject safety.
- Males between 30 and 55 years of age inclusive, at the time of signing the informed consent.
Key exclusion criteria (24 listed)
- Subject is mentally or legally incapacitated.
- History of current significant medical illness including cardiovascular thrombotic events, myocardial infarction, stroke or other cardiac disease, hypertension, peptic ulcer disease or gastrointestinal bleeding, skin disorders, hematological disease, bronchospastic respiratory disease, asthma, diabetes mellitus, renal or hepatic insufficiency, or any other illness that the investigator deems clinically significant for exclusion of the subject from the study.
- Diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the opinion of the study investigator or GSK medical monitor would prevent use of an anticholinergic and therefore study participation.
- A mean QTcF value at screening >450msec, the QTcF of all 3 screening ECGs are not within 10% of the mean, or an ECG that is not suitable for QT measurements (e.g. poorly defined termination of the T wave).
- A history of elevated resting blood pressure or a mean blood pressure equal to or higher than 139/89 millimeters of mercury (mmHg) 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 |
|---|---|---|
| [14C]Umeclidinium 18.5 mgUmeclidinium will be supplied as clear, colorless solution, free from visible particulates, single dose, topical solution in clear glass jars. Dosage of 18.5 mg of Umeclidinium per gram is equivalent to 22 mg per gram of the bromide salt. | Drug | Cohort A, Cohort B, Cohort C, Cohort D |
Primary outcome
PK Assessment (Cmax) for [14C] umeclidinium and total radioactivity
Time frame: Day 1: Predose, 2, 4, 5, 6, 8, 8.5, 9, 9.5, 10, 11, 12, 13, 14 and 16 hrs postdose. Day 2: 24, 30 and 36 hrs. Day 3 (48 hours), Day 4 (72 hrs) and up to follow-up Day 14.
Blood sample will be collected for PK assessment including maximum observed plasma concentration (Cmax).
PK Assessment (tmax) for [14C] umeclidinium and total radioactivity
Time frame: Day 1: Predose, 2, 4, 5, 6, 8, 8.5, 9, 9.5, 10, 11, 12, 13, 14 and 16 hrs postdose. Day 2: 24, 30 and 36 hrs. Day 3 (48 hours), Day 4 (72 hrs) and up to follow-up Day 14.
Blood sample will be collected for PK assessment including time to Cmax (tmax).
PK Assessment (AUC) for [14C] umeclidinium and total radioactivity
Time frame: Day 1: Predose, 2, 4, 5, 6, 8, 8.5, 9, 9.5, 10, 11, 12, 13, 14 and 16 hrs postdose. Day 2: 24, 30 and 36 hrs. Day 3 (48 hours), Day 4 (72 hrs) and up to follow-up Day 14.
Blood sample will be collected for PK assessment including area under the plasma concentration-time curve (AUC) from time 0 to the last quantifiable sample (AUC0-last), AUC from time zero to 12 hrs or 24 hrs (AUC0-12 and AUC0-24, respectively), AUC from time zero to time infinity [AUC (0-infinity)].
PK Assessment (t1/2) for [14C] umeclidinium and total radioactivity
Time frame: Day 1: Predose, 2, 4, 5, 6, 8, 8.5, 9, 9.5, 10, 11, 12, 13, 14 and 16 hrs postdose. Day 2: 24, 30 and 36 hrs. Day 3 (48 hours), Day 4 (72 hrs) and up to follow-up Day 14.
Blood sample will be collected for PK assessment including apparent terminal phase half-life (t1/2).
Compartmental modeling of absorption rate for [14C] umeclidinium
Time frame: Day 1: Predose, 2, 4, 5, 6, 8, 8.5, 9, 9.5, 10, 11, 12, 13, 14 and 16 hrs postdose. Day 2: 24, 30 and 36 hrs. Day 3 (48 hours), Day 4 (72 hrs) and up to follow-up Day 14.
Compartmental modeling may be conducted to characterize the absorption rate constants.
Compartmental modeling of elimination rate for [14C] umeclidinium
Time frame: Day 1: Predose, 2, 4, 5, 6, 8, 8.5, 9, 9.5, 10, 11, 12, 13, 14 and 16 hrs postdose. Day 2: 24, 30 and 36 hrs. Day 3 (48 hours), Day 4 (72 hrs) and up to follow-up Day 14.
Compartmental modeling may be conducted to characterize the elimination rate constants.
8 secondary outcomes
Determine the amount of Umeclidinium absorbed in the skin
Time frame: Day 1 (and Day 2 if required)
Safety Assessment for AEs
Time frame: From first dose up to Follow-up (Day 14)
Safety Assessment for ECGs, and telemetry
Time frame: From Screening up to Follow-up (Day 14)
Safety Assessment for hematology laboratory parameters
Time frame: From Screening up to Follow-up (Day 14)
Safety Assessment for measurement of blood pressure
Time frame: From Screening up to Follow-up (Day 14)
Number of subjects with application site skin irritation
Time frame: From Day 1 up to Follow-up (Day 14)
Safety Assessment for clinical chemistry laboratory parameters
Time frame: From Screening up to Follow-up (Day 14)
Safety Assessment for measurement of pulse rate
Time frame: From Screening up to Follow-up (Day 14)
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 15 May 2017.
- 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 117157 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 [14C]Umeclidinium 18.5 mg in people with Hyperhidrosis, run by GlaxoSmithKline at 1 site in Netherlands.
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 24 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 15 May 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 Netherlands. 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?
PK Assessment (Cmax) for [14C] umeclidinium and total radioactivity (time frame: Day 1: Predose, 2, 4, 5, 6, 8, 8.5, 9, 9.5, 10, 11, 12, 13, 14 and 16 hrs postdose. Day 2: 24, 30 and 36 hrs. Day 3 (48 hours), Day 4 (72 hrs) and up to follow-up Day 14.). The study lists 6 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 15 May 2017.