Health Trials

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

ConditionMalaria
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorMedicines for Malaria Venture

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male and female volunteers aged 18-55 years of age (inclusive) at the time of signing the Informed Consent.

Total body weight (BW) ≥50 kg, and a body mass index (BMI) of 18-32 kg/m2 (inclusive).

Residence within the study area.

Judged healthy based on a comprehensive clinical assessment, including a detailed medical history and full physical examination.

Disqualifiers

Evidence of clinically significant, gastrointestinal, cardiac, lung, hepatic, neurologic, psychiatric, rheumatologic, autoimmune, dermatologic, hematological, oncologic, or renal disease by anamnesis, physical examination, and/or laboratory tests.

Known Central Nervous System disorders or a history of seizures.

Any surgery that may affect drug bioavailability (excluding appendectomy and cholecystectomy).

Signs and symptoms of uncomplicated or severe malaria. An asymptomatic Plasmodium infection is not exclusionary.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Cohort 1 low dose lotilaner with a high-fat meal

    Drug

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

  • Cohort 1 low dose placebo with a high-fat meal

    Other intervention

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

  • Cohort 2 high dose lotilaner in fasted state

    Drug

    Participants will receive high dose lotilaner in a fasted state

  • Cohort 2 high dose placebo in fasted state

    Other intervention

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

  • Cohort 3 high dose lotilaner with a high-fat meal

    Drug

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

  • Cohort 3 high dose placebo with a high-fat meal

    Other intervention

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

Treatment groups

75 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Cohort 1Experimental treatment 1 intervention
Group B: Cohort 2Experimental treatment 1 intervention
Group C: Cohort 3Experimental treatment 1 intervention
Group D: low dose placebo with high-fat mealPlacebo comparator 1 intervention
Group E: high dose placebo in fasted statePlacebo comparator 1 intervention
Group F: high dose placebo with a high-fat mealPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Safety and tolerability of Lotilaner

All-cause mortality, Serious Adverse Events, Other (not including Serious) Adverse Events (frequency threshold:5%)

Time frame
From hour 0 on Day 1 through the end of the study (Day 169)

Secondary outcomes

1

Anopheles gambiae mosquito survivorship (% alive) following membrane feeding on participant blood

Mosquitocidal activity of Lotilaner against Anopheles gambiae mosquitoes (single blood feeding timepoint)

Time frame
Follow up day 34 (5 days post mosquito feeding, on blood collected from participants at follow up day 29)
2

Anopheles gambiae mosquito survivorship (% alive) following membrane feeding on participant blood

Mosquitocidal activity of lotilaner against Anopheles gambiae mosquitoes (multiple blood feeding timepoints)

Time frame
Follow up 1-5 days post mosquito feeding on blood collected from participants between study days 1 to 85, according to the schedule of assessments
3

Aedes Aegypti mosquito survivorship (% alive) following membrane feeding on participant blood

Mosquitocidal activity of Lotilaner against Aedes aegypti mosquitoes (multiple blood feeding timepoints)

Time frame
Follow up 1-5 days post mosquito feeding on blood collected from participants between study days 1 to 85, according to the schedule of assessments
4

Maximum observed concentration (Cmax) of Lotilaner in whole blood

Pharmacokinetics of single dose of Lotilaner in healthy adults

Time frame
At protocol-specified timepoints through the end of pharmacokinetic sampling, an average of 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medicines for Malaria Venture

Lead sponsor

Radboud University Medical Center

Collaborator

London School of Hygiene and Tropical Medicine

Collaborator

Malaria Research and Training Center, Bamako, Mali

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: