Gastrointestinal infections caused by whipworm (Trichuris trichiura), hookworm (Necator americanus or Ancylostoma duodenale) and/or roundworm (Ascaris lumbricoides). MedDRA version: 20.0 Level: PT Classification code 10061201 Term: Helminthic infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: emodepside
Pharmaceutical Form: Tablet
INN or Proposed INN: Emodepside
CAS Number: 155030-63-0
Current Sponsor code: BAY 44-4400
Concentration unit: mg milligram(s)
Concentration type: e
Sponsors
Swiss Tropical and Public Health Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or non-pregnant (confirmed by a negative serum pregnancy test) and non-breastfeeding female participants aged 12 years and older. 2. T. trichiura as a single infection or co-infection with hookworm and/or A. lumbricoides, confirmed by presence of T. trichiura eggs assessed by Kato-Katz thick smears from two stool samples (infection intensity defined as number of eggs per gram of stool (EPG): (1) light (1-999 EPG), (2) moderate to heavy (=1000 EPG). 3. A minimum infection intensity of 24 eggs per gram of stool at baseline and at least two positive slides out of the four slides assessed at baseline. 4. Written informed consent signed by the participant and/or legally authorized representative(s) according to the participant's age as established per local regulations. In addition, participant's assent is required as applicable by local laws and regulations for adolescents of 12-17 years of age. 5. Women of childbearing potential must agree to use an effective, culturally appropriate contraceptive measure from at least 28 days prior to first dosage for hormonal contraceptives only and for non-hormonal contraceptive measures from screening Visit 2 until End of Study Visit. Are the trial subjects under 18? yes Number of subjects for this age range: 232 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 83 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Presence of any systemic illnesses, renal and/or hepatic impairment, any other acute or chronic health conditions or congenital disorders which, in the opinion of the Investigator, would make the participant unsuitable for participation in a clinical study or may interfere with the efficacy, safety, and/or pharmacokinetic (PK) evaluation of the study drug. 2. Any of the following: 2.1 Platelet 3x upper limit of normal (ULN) 2.3 Total bilirubin >2xULN 2.4 Estimated Glomerular Filtration Rate (eGFR) <90 ml/min/1.73 m2 (adolescents) or estimated creatinine clearance (CrCl) <90 ml/min (adults) 3. Treatment with the following anthelminthic drugs: albendazole, mebendazole, ivermectin, within 28 days before the first dose of study intervention or planned before End of Study Visit. 4. Use of sensitive CYP3A4 substrates within 14 days before the start of the first study intervention and until at least 14 days after the last administration of study intervention (detailed list of prohibited medication is provided in Section 6.5.1). 5. Treatment with metronidazole within 2 days before the first dose of study intervention or planned before 24 hours after last administration of study intervention. 6. Previous assignment to a study intervention for another study planned to be administered during the period the participant is enrolled in this study (from date of informed consent to last follow-up). 7. Known allergy/hypersensitivity to mebendazole and/or emodepside
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: Cured of A. lumbricoides infection, determined by negative Kato-Katz thick smears in two stool samples taken at the Test of Cure Visit. This endpoint is only applicable for the subgroup of participants co-infected with A. lumbricoides at baseline. Safety: Occurrence of treatment-emergent adverse events (TEAEs) defined as any adverse event (AE) that occurred or worsened after the first dose of the study intervention up to 21 days after the last dose of study intervention.;Timepoint(s) of evaluation of this end point: Efficacy: 14 to 21 days after end of treatment. Safety: From the first dose of the study intervention up to 21 days after the last dose of study intervention. | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy: Assess the superiority of a single-dose regimen of emodepside compared to a multiple-dose regimen of mebendazole, measured as cure of T. trichiura at the Test of Cure Visit ;Secondary Objective: Efficacy: Assess the non-inferiority of a single-dose regimen of emodepside compared to a multiple-dose regimen of mebendazole, measured as cure of A. lumbricoides at the Test of Cure Visit Safety: Investigate the safety and tolerability of emodepside ;Primary end point(s): Cured of T. trichiura infection, determined by negative Kato-Katz thick smears in two stool samples taken at the Test of Cure Visit.;Timepoint(s) of evaluation of this end point: 14 to 21 days after end of treatment. | — |
Countries
Tanzania, United Republic of
Contacts
Public ContactProf. Dr. Jennifer Keiser
Swiss Tropical and Public Health Institute
Outcome results
None listed