Investigation of Ascending Concentrations of Glycopyrronium Bromide (GPB) in a Topical Formulation in Subjects With Axillary Hyperhidrosis

Inclusion criteria

• Diagnosis of moderate to severe primary axillary hyperhidrosis whose HDSS score is 2, 3 or 4
• At least 50 mg in males or 25 mg in females of spontaneous resting axillary sweat production in one axilla measured gravimetrically at room temperature/humidity (about 25°C / 20-50%) over a period of 5 minutes.
• Male and female subjects in the age of 18 to 65 years at the time of informed consent and a body mass index (BMI) of 18-32 kg/m2.
• Corrected QT (QTc) ≤450 msec, or QTc <480 msec in subjects with bundle branch block.
• Able to comply with protocol requirements, including overnight stays, blood sample collections as defined in the protocol subjects.
• Willing and able to provide written informed consent.

Exclusion criteria

• Known allergy to any of the components in the investigational product.
• Hypersensitivity against glycopyrrolate
• Secondary hyperhidrosis, for example, hyperhidrosis that is secondary to other underlying diseases including hyperthyroidism, lymphoma and malaria, climacteric hyperhidrosis.
• Previous surgical treatment of hyperhidrosis including sympathectomy, surgical debulking of the sweat glands, subcutaneous tissue curettage and ultrasonic surgery.
• Botulinum toxin treatment in the prior 9 months.
• Present or history of neuromuscular disease.
• Angle closure glaucoma or its precipitation (narrow angle).
• Mycotic, other skin infections and other dermal disorder including infection at anticipated application sites in either axilla.
• Significant cardiac arrhythmia such as tachycardiac atrial fibrillation and very frequent extrasystoles.
• Subject with diabetes mellitus.
• Subjects with ileus, gastrointestinal stenosis, pronounced chronic inflammatory bowel disease, toxic megacolon.
• Subjects with epilepsy.
• Use of antiperspirants containing aluminium chloride and deodorants, any oral herbal medicine treatments or any other topical treatments for hyperhidrosis within 7 days prior to study treatment.