Evaluation of the safety, tolerability, pharmacokinetics and pharmacodynamics of topically applied NT-077 (tiotropium bromide) in healthy volunteers.

Completed

• Conditions: primary hyperhidrosis is a not well-delineated condition; excessive sweat production; hyperhydrosis

• Registration Number: NL-OMON50872
• Lead Sponsor: otoxins Holding B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2022-08-26
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 4

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>PK: plasma concentration-time profile. If data allow (i.e. if sufficient<br /><br>systemic exposure is attained), a non-compartmental analysis of the plasma<br /><br>concentration-time profiles will be performed including determination of<br /><br>AUC0-t, AUC0-inf, Cmax, tmax, *Z, t*. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Pharmacodynamics: evoked sweat production by acetylcholine (using Q-sweat<br /><br>device), AUC (amount of sweat) and latency of Sweat response.<br /><br>Adverse events reporting, local tolerance, vital signs (pulse rate, blood<br /><br>pressure (semi-recumbent), temperature).</p><br>