Cancer
Conditions
Interventions
Sponsors
University of North Carolina Chapel Hill Department of Obstetrics and Gynecology
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: - Age 18 years to 65 years - Negative pregnancy test at screening - Weight =50 Kg at study entry* - Willingness to use contraception (hormonal or barrier) during the 5-day study dosing phase if of childbearing age (less than 50 years of age) - Ability and willingness to provide informed consent - Plan to reside in the study location during the study period - Agrees for samples without identifiers to be shipped outside of Kenya for testing *Justification for weight criteria: A minimum body weight of 50Kg will meet the planned artesunate dosing of =4 mg/Kg for which excellent safety data is available.
Exclusion criteria
Exclusion criteria: - Current pregnancy or breastfeeding status - History of total hysterectomy - Known allergy to Artesunate - Have a medical comorbidity that in the opinion of the investigator would interfere with study participation - Currently receiving artemisinin-based agents for malaria treatment or completed artemisinin-based treatment within the previous 3 days.* - Male at birth - Current use of efavirenz antiretroviral therapy - Positive malaria antigen test at screening *Based on dihydroartesunate (artesunate’s active metabolite) half-life of between 0.5-1.5 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration versus time curve (AUC) of dihydroartemisinin (DHA) following five consecutive days of self-administration of 200mg Artesunate vaginal inserts (pessaries) among healthy women in Kenya. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Plasma AUC of Artesunate following 5-day self-administration of 200mg Artesunate vaginal inserts (pessaries) 2. Maximum concentration of Artesunate (Cmax) following 5-day self-administration of 200mg Artesunate vaginal inserts (pessaries) | — |
Countries
Kenya
Contacts
Public ContactCirilus Ogollah
Co Investigator
Outcome results
None listed