This study will be a single center, open-label study of a single concentration of ANR- 001.1. The solution will be applied to the scalp of 14 male subjects by study staff once daily for 7 days.
At screening, subjects will sign informed consent and inclusion and exclusion will be reviewed for each subject. Screening data will include demographics, medical history, concomitant medications, physical examination, weight, O2 sat, vital signs laboratory evaluation (CMP, CBC, UA), and ECG. At Day 1, a physical exam, weight, O2 sat, vital signs (including BP, pulse, respiratory rate and temperature) and review of concomitant medications will be performed, and admission criteria reviewed. If criteria are met, the study staff will administer the first dose of study medication to the area of hair loss on the scalp (8 cm x 6 cm). If there is no hair loss the dose will be administered to the crown of the head (8 cm x 6 cm). The study staff will continue to administer the study medication to the same area of the scalp of the subject, once daily for Study Days 1, 2, 3, 4, 5, 6, and 7. Daily subject visits will include vital signs, review of adverse events and concomitant medications. PK draws and ECGs will take place at Study Days 1, 2, 7 and 8, following the first dose and the last doses, respectively.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Topical formulation applied once a day.
Pharmacokinetic data: Cmax
Individual and mean maximum plasma concentration (Cmax)
Time frame: 7 days
Pharmacokinetic data: tmax
Individual and mean tmax
Time frame: 7 days
Pharmacokinetic data: Half-life (t1/2)
Individual and mean half-life (t1/2)
Time frame: 7 days
Pharmacokinetic data: AUC
Individual and mean area under the concentration-time curve calculated from time zero to the last observable concentration at time t (AUC0-t)
Time frame: 7 days
Pharmacokinetic data: Drug clearance
Individual and mean apparent clearance of drug from plasma
Time frame: 7 days
Safety : Skin TEAEs
Incidence of treatment-emergent adverse events related to skin irritation at the administration site
Time frame: 7 days
Safety: Systemic TEAEs
Incident of systemic treatment-emergent adverse events
Time frame: 7 days
Safety: Evaluation of QTs Interval Prolongation
Change from baseline in the frequency of marked QTc prolongation at each visit where ECG is performed
Time frame: 7 days
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