IGHID 12333 Study
- Conditions
- Cancer
- Registration Number
- PACTR202402687748210
- Lead Sponsor
- niversity of North Carolina Chapel Hill Department of Obstetrics and Gynecology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 12
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.
-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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)