Phase I Research Evaluating Pharmacokinetics Antiviral Readiness for Ebola/Marburg (PREPARE-Filo-1)

A Phase I, Open-Label Study to Assess the Safety, Tolerability, and Pharmacokinetics of Obeldesivir and Galidesivir in Healthy African Adults Living With and Without HIV

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

PACTR

Registry ID

PACTR202510883361706

Enrollment

132

Registered

2025-10-22

Start date

2026-05-01

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ebola

Interventions

Study A Obeldesivir

Study B Galidesivir

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Adults aged 18–55 years • BMI 18–30 kg/m² • HIV-positive participants on stable ART =12 weeks • HIV-negative participants with documented negative test • Able and willing to provide informed consent

Exclusion criteria

Exclusion criteria: • Significant hepatic or renal impairment • Clinically relevant abnormal labs at screening • Pregnancy or breastfeeding • Hypersensitivity to nucleoside analogs or monoclonal antibodies • Use of comedication with known drug-drug interactions to study drugs • Participation in another investigational trial within 30 days • Active acute illness at enrollment

Design outcomes

Primary

Measure	Time frame
Peak Concentration (CMax) of obeldesivir and galidesivir in Plasma;Time to maximum concentration (TMax) of obeldesivir and galidesivir in Plasma;Terminal elimination half-life of obeldesivir and galidesivir in plasma;Area under the concentration-time curve (AUC) of obeldesivir and galidesivir	—

Secondary

Measure	Time frame
Geometric mean ratio and 90% confidence intervals of obeldesivir and galidesivir area under concentration-time curve, with and without antiretroviral therapy.;Number of adverse events categorized by body system;Percentage of participants with adverse events categorised by body system;Geometric mean ratio and 90% confidence intervals of obeldesivir and galidesivir CMax with and without antiretroviral therapy.;Geometric mean ratio and 90% confidence intervals of obeldesivir and galidesivir TMax with and without antiretroviral therapy.;Geometric mean ratio and 90% confidence intervals of obeldesivir and galidesivir terminal elimination half-life with and without antiretroviral therapy.	—

Measure

Time frame

Geometric mean ratio and 90% confidence intervals of obeldesivir and galidesivir area under concentration-time curve, with and without antiretroviral therapy.;Number of adverse events categorized by body system;Percentage of participants with adverse events categorised by body system;Geometric mean ratio and 90% confidence intervals of obeldesivir and galidesivir CMax with and without antiretroviral therapy.;Geometric mean ratio and 90% confidence intervals of obeldesivir and galidesivir TMax with and without antiretroviral therapy.;Geometric mean ratio and 90% confidence intervals of obeldesivir and galidesivir terminal elimination half-life with and without antiretroviral therapy.

—

Countries

Democratic Republic of the Congo, Tanzania, Uganda

Contacts

Public ContactDaniel Kiiza

Program Manager

dkiiza@idi.co.ug00256777666183

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026