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

• Status: Completed
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to assess the safety, tolerability, pharmacokinetics (PK) and efficacy of escalating concentrations of GPB in subjects with axillary hyperhidrosis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel
• Collaborators: Charles River Biopharmaceutical Services GmbH; FGK Clinical Research GmbH; Nuvisan GmbH
• Treatments: Bromides; Glycopyrrolate

Criteria

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.