primary hyperhidrosis is a not well-delineated condition excessive sweat production
Conditions
Interventions
Topically applied spray formulation with NT-077 or placebo.
Sponsors
Notoxins Holding B.V.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Male between 18 and 60 years of age (both inclusive) at the screening visit. 2. Body mass index between 18 and 30 kg/m2. (both inclusive) 3. Subject is judged to be in good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests performed at the screening visit and prior to administration of the initial dose of study drug. 4. Willing to shave both axillaries prior and during the study 5. Subject is willing to refrain from the use of antitransparant or antiperspirant sprays containing aluminum salts (e.g. Odorex extra dry, Syneo antitransparant spray and Odaban anti-transparent spray) from at least 7 days prior to first administration to and including the day of the last assessment of the last treatment period, and from the use of deodorant without aluminum salts from 24 hours prior to dosing until Day 2 during in the treatment periods of Part I and from Day 1 to 9 (including) in Part II.
Exclusion criteria
Exclusion criteria: 1. History of known sensitivity or intolerability to tiotropium bromide or to any related compound (including but not limited to ipratropium), or history of significant multiple and/or severe allergies (including latex allergy) or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food. 2. History of clinically significant endocrine, gastrointestinal, cardiovascular, haematological, hepatic, immunological, renal, respiratory, neoplastic or genitourinary abnormalities or diseases. Subjects with a history of uncomplicated kidney stones or childhood asthma may be enrolled in the study at the discretion of the investigator. 3. History of glaucoma or first line family members with glaucoma. 4. Clinical significant history of skin diseases, including but not limited to eczema. 5. Subjects suffering from primary hyperhidrosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK: plasma concentration-time profile. If data allow (i.e. if sufficient systemic exposure is attained), a non-compartmental analysis of the plasma concentration-time profiles will be performed including determination of AUC0-t, AUC0-inf, Cmax, tmax, *Z, t*. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamics: evoked sweat production by acetylcholine (using Q-sweat device), AUC (amount of sweat) and latency of Sweat response. Adverse events reporting, local tolerance, vital signs (pulse rate, blood pressure (semi-recumbent), temperature). | — |
Countries
Netherlands
Outcome results
None listed