Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Almirall, S.A.
With
Allergan
Age
9–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Successfully completed participation in Phase 3 study of sarecycline (SC1401 or SC1402)
Signed informed consent or assent form
Body weight between 33 kg and 136 kg, inclusive
Negative urine pregnancy test for females of childbearing potential
Agrees to use effective method of contraception throughout study, if applicable.
Able to fulfill protocol requirements, indicated willingness to participate in study and agrees to all study procedures by providing written informed consent/assent and authorization to disclose (personal health information)
You may not be if
Currently participating in another clinical study, unless it is a pharmacokinetic sarecycline study and participation approved by medical monitor; has received investigational medication (except sarecycline) within 30 days of enrollment.
Discontinued participation in a Phase 3 study with sarecycline for any reason
Had poor compliance wtih study requirements/study drug dosing in a Phase 3 study with sarecycline
Is receiving/planning to receive any systemic acne medication, systemic retinoids, systemic corticosteroids or any androgen/anti-androgenic therapy (eg, testosterone, spironolactone)
Is pregnant, lactating or planning a pregnancy during the study period
Has a significant intercurrent illness (including clinically significant abnormality in clinical laboratory tests), psychiatric disorder, or other factors that, in the opinion of the Investigator or Medical Monitor, precludes participation in the study
Is judged by the Investigator to be unsuitable for any reason
