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Safety, Tolerability, Pharmacokinetics, and Mosquitocidal Activity of Lotilaner in Healthy Participants in Mali.

NCT07758985 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-08-11

No results posted yet for this study

Summary

This is a Phase 1b, single-cente, randomized, double-blind, placebo-controlled proof-of-concept study evaluating the safety, tolerability, pharmacokinetics and mosquitocidal activity of single oral doses of lotilaner in healthy, adult participants living in Mali.

Conditions

Interventions

DRUG

Cohort 1 low dose lotilaner with a high-fat meal

Participants will receive a single low dose of lotilaner with a high-fat meal

OTHER

Cohort 1 low dose placebo with a high-fat meal

Participants will receive a single low dose of placebo with a high-fat meal

DRUG

Cohort 2 high dose lotilaner in fasted state

Participants will receive high dose lotilaner in a fasted state

OTHER

Cohort 2 high dose placebo in fasted state

Participants will receive a single high dose of placebo in a fasted state

DRUG

Cohort 3 high dose lotilaner with a high-fat meal

Participants will receive a single high dose of lotilaner after a high-fat meal

OTHER

Cohort 3 high dose placebo with a high-fat meal

Participants with receive a single high dose of placebo with a high-fat meal

Sponsors & Collaborators

  • Radboud University Medical Center

    collaborator OTHER

  • London School of Hygiene and Tropical Medicine

    collaborator OTHER

  • Malaria Research and Training Center, Bamako, Mali

    collaborator OTHER

  • Medicines for Malaria Venture

    lead OTHER

Principal Investigators

  • Prof. Alassane Dicko, MD, PhD · MRTC, Université des Sciences Techniques et Technologies de Bamako, Mali

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-08-31
Completion
2027-08-31
FDA Drug
Yes

Countries

  • Mali

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07758985 on ClinicalTrials.gov