Pharmacokinetics of Intravaginal, Self-administered Artesunate Vaginal Pessaries Among Women in Kenya

NCT06263582 | Completed Phase 1 Results

• 2 other identifiers: IGHID12333K12HD103085
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the pharmacokinetics of Artesunate (AS) and dihydroartemisinin (DHA), the active metabolite of Artesunate, following intravaginal use at the dosing and frequency being studied for cervical precancer treatment. A secondary objective is to investigate safety among study participants.

Conditions

Cervix Cancer; Cervix Intraepithelial Neoplasia Grade 3; Cervix; Intraepithelial Neoplasia, Grade I; Cervix; Intraepithelial Neoplasia, Grade II

Keywords

Artesunate; dihydroartemisinin; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• To Determine the Area Under the Plasma Concentration Versus Time Curve (AUC) of Dihydroartemisinin

  To determine the area under the plasma concentration versus time curve (AUC) of dihydroartemisinin (DHA) following five consecutive days of self-administration of 200mg Artesunate vaginal inserts (pessaries). Mean DHA AUC will be submitted.

  Day 5

Secondary Outcomes (12)

• To Determine the Area Under the Plasma Concentration Versus Time Curve (AUC) of Artesunate (AS)

  Day 5

• To Determine the Maximum Concentration of Artesunate (AS)

  Day 5

• To Determine the Maximum Concentration of Dihydroartemisinin (DHA) (Cmax)

  Day 5

• To Determine the Time to Maximum Concentration (Tmax) of Artesunate (AS) Following Five Consecutive Days

  Day 5

• To Determine the Time to Maximum Concentration (Tmax) of Dihydroartemisinin (DHA

  Day 5

Study Arms (1)

Artesunate vaginal inserts/ pessaries

EXPERIMENTAL

Artesunate vaginal inserts/pessaries are used as a treatment for cervical precancerous lesions.

Drug: Artesunate pessary; Diagnostic Test: blood draws for pharmacokinetics of the study drug

Interventions

Artesunate pessary DRUG

Subjects will use the study pessaries, placed in the vagina every day for 5 consecutive days.

Artesunate vaginal inserts/ pessaries

blood draws for pharmacokinetics of the study drug DIAGNOSTIC_TEST

On day 5, all participants will have their blood draws before they use the pessary, and at 15 min, 30 mins, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours after inserting the pessary. Blood samples will be tested for the pharmacokinetics of the study drug.

Artesunate vaginal inserts/ pessaries

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Women are eligible
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Negative pregnancy test at screening
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Lumumba Sub-County Hospital

Kisumu, Kenya

Location

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Cervical Dysplasia; Carcinoma in Situ; Lymphoma, Follicular

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Precancerous Conditions; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Limitations and Caveats

Pharmacokinetic (PK) sampling from 0 to 8 hours after intravaginal administration of artesunate was not sufficient to capture the elimination phase of the drug and its metabolite. As a result, key plasma pharmacokinetic parameters including apparent clearance (CL/F), apparent volume of distribution (Vd/F), elimination half-life (t½), and area under the concentration-time curve from time zero to infinity (AUC₀-∞) could not be estimated.

Results Point of Contact

• Title: Sorgi Kate
• Organization: UNC Lineberger Comprehensive Cancer Center

kasorgi@email.unc.edu

919-966-5280

Study Officials

• Chemtai Mungo, MD, MPH, FACOG

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 16, 2024
• Study Start: May 29, 2024
• Primary Completion: August 14, 2024
• Study Completion: August 14, 2024
• Last Updated: August 19, 2025
• Results First Posted: August 19, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)