Healthy VolunteersPhase 1NCT02661178

First in Man Clinical Trial of Emodepside (BAY 44-4400)

A Phase 1 study testing emodepside (BAY 44-4400) in people with Healthy Volunteers, run by Drugs for Neglected Diseases at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will investigate the safety, tolerability, and pharmacokinetics of single ascending doses of emodepside (BAY 44-4400) in healthy male volunteers. This study will also conduct an exploratory investigation of the relative bioavailability of emodepside administered as tablets and determine the effect of food… Read more about this study

Who is it for?: Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: emodepside (BAY 44-4400)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 79 participants
Where: 1 siteUnited Kingdom
Study dates: Dec 2015to 27 Mar 2017
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Male, Caucasian volunteers, deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine. Optionally, after further evaluation during the study, at the sponsor's discretion other ethnic groups may be recruited.
Aged 18 to 55 years.
With a body mass index (BMI; Quetelet index) in the range of 18 to 30.1 kg/m2 at screening.
Sufficient intelligence to understand the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial.
Willingness to give written consent to participate, after reading the information and consent form, and after having the opportunity to discuss the trial with the investigator or his delegate

Who cannot join

Participation in another clinical trial within 3 months prior and during the study, or 5-times the half-life of the drug tested in the previous clinical trial, whichever is longer (time calculated relative to the last dose in the previous clinical trial)
Clinically relevant abnormal medical history, concurrent medical condition, acute or chronic illness or history of chronic illness sufficient to invalidate the subject's participation in the trial or make it unnecessarily hazardous.
Surgery (eg stomach bypass) or medical condition that might affect absorption of study drug taken orally.
Presence of abnormal physical findings, ECG, or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the subject.
Positive tests for hepatitis B \& C, HIV
Presence or history of drug or alcohol abuse during the last 10 years, or intake of more than 21 units of alcohol weekly.

Show all 20Show fewer

Regular daily consumption of more than one liter of xanthine-containing beverages
Regular daily consumption of more than 5 cigarettes daily, or use more than 3 grams (1/8 ounce) of tobacco
Use of a prescription medicine during the 28 days before the first dose of trial medication or use of an over-the-counter medicine, with the exception of acetaminophen (paracetamol), during the 7 days before the first dose of trial medication
Use of dietary supplements or herbal remedies (such as St John's Wort) known to interfere with the CYP3A4 and/or P-gp metabolic pathways during the 28 days before the first dose of trial medication (see list in Study Procedures Manual)
Additional exclusion criteria for cohort with ophthalmological assessments:
No contact lenses wear within 1 month prior to first dose of IMP. Contact lenses wear is not permitted during the study
Any ocular disorder for which topical ocular therapy is currently or chronically prescribed, including inflammatory eye disease (dry eye allergic conjunctivitis [seasonal allergic conjunctivitis, vernal keratoconjunctivitis, atopic keratoconjunctivitis], uveitis and glaucoma)
Past history of ocular disease requiring ongoing treatment
Past ocular surgery including laser or other refractive corneal surgery
Evidence of eye irritation, visual difficulties, corneal opacity, ocular surface (corneal or conjunctival damage, with or without ocular symptoms)
Evidence of narrow anterior chamber angles causing increased risk of acute glaucoma
Evidence of ocular media opacity including lens opacity/vitreous opacities
Evidence of retinal or optic nerve pathology
Evidence of pronounced colour blindness, as indicated by an Ishihara score of 9/13 or below

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Hammersmith Medicines Research
London, NW10 7EW

Other trials in United Kingdom

About this study

Official title: A Phase 1, Blinded, Randomized, Placebo Controlled, Parallel-Group, Single-Dose, Dose-Escalation Study to Investigate Safety, Tolerability, and Pharmacokinetics of Emodepside (BAY 44-4400) After Oral Dosing in Healthy Male Subjects

Conditions: Healthy Volunteers
Being tested: emodepside (BAY 44-4400), placebo
Keywords: Parasitic Diseases, Helminthiasis, Nematode Infections, Secernentea Infections, Spirurida Infections, Filariasis, Skin Diseases, Parasitic, Skin and Connective Tissue Diseases, Skin Diseases, Skin Diseases, Infectious, Depsipeptides, Emodepside, Neglected disease, Africa, New drug, Oral drug, Parasite, Anthelmintic drug, Cyclooctadepsipeptide, Single ascending dose
Medical subject headings: Parasitic Diseases, Helminthiasis, Nematode Infections, Secernentea Infections, Spirurida Infections, Filariasis, Skin Diseases, Parasitic, Skin and Connective Tissue Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

emodepside (BAY 44-4400)Drug
placeboDrug

Study groups in NCT02661178
Study group	Role	What they receive
emodepside (BAY 44-4400)	Experimental	Up to 10 cohorts with single ascending dose Receives: Drug: emodepside (BAY 44-4400)
placebo of emodepside (BAY 44-4400)	Placebo comparator	Up to 10 cohorts with single ascending dose Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and Tolerability as Measured by Adverse Events
Deaths, serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs)
Measured: Up to 14 days post dose (may be extended to 21 days)
Safety and Tolerability as Measured by Physical and Neurological Examination Findings
Abnormal or clinically significant neurological examination findings during the study or reported as an AE
Measured: Up to 14 days post dose (may be extended to 21 days)
Safety and Tolerability as Measured by Vital Signs
Vital signs included heart rate, systolic and diastolic blood pressure,
Measured: Up to 14 days post dose (may be extended to 21 days)
Safety and Tolerability as Measured by 12-lead ECG
The following variables were recorded in 12-lead ECGs and extracted from continuous 12-lead ECG recordings: ventricular rate, PR interval, QRS interval, QTcB and QTcF interval.
Measured: Up to 14 days post dose (may be extended to 21 days)
Safety and Tolerability as Measured by Clinical Laboratory Parameters
Clinical laboratory parameters included hematology, biochemistry, serology and coagulation in blood samples and urinalysis in urine samples
Measured: Up to 14 days post dose (may be extended to 21 days)
Safety and Tolerability as Measured by Ophthalmological Examination Findings in One Study Arm Only
Subjects attended a specialist eye hospital for ophthalmology assessments by a Consultant Ophthalmologist. Opthalmology assessments included:ocular symptoms, past ocular history, auto-refraction, best corrected distance visual acuity, color vision assessment, amsler grid assessment, ocular alignment and ocular motility assessment, confrontation visual field assessment, slit lamp examination (anterior segment), intraocular pressure (Goldmann Tonometry), optical coherence scanning of tomography, post mydriatic ocular media (at Screening visit 2 only) and retinal examination with slit lamp and lens.
Measured: Up to 14 days post dose (may be extended to 21 days)

Secondary outcomes (18)

The AUC∞ of Emodepside in Plasma
The area under the plasma drug concentration versus time curve from time zero to infinity (AUC∞)
Measured: From pre-dose until 336h post-dose (may be extended to 504h post-dose)
The AUC∞/D of Emodepside in Plasma
Dose-normalized area under the plasma drug concentration versus time curve from time zero to infinity (AUC∞/D), calculated as AUC∞/Dose administered.
Measured: From pre-dose until 336h post-dose (may be extended to 504h post-dose)
The Cmax of Emodepside in Plasma
Maximum observed plasma concentration (Cmax) was obtained directly from the concentration-time data
Measured: From pre-dose until 336h post-dose (may be extended to 504h post-dose)
The Cmax/D of Emodepside in Plasma
Dose-normalized observed maximum plasma concentration (Cmax/D) was calculated as Cmax/Dose administered
Measured: From pre-dose until 336h post-dose (may be extended to 504h post-dose)
The Cmax, Norm of Emodepside in Plasma
The observed maximum plasma concentration (Cmax) normalized by dose and body weight was calculated as Cmax/(Dose administered*body weight)
Measured: From pre-dose until 336h post-dose (may be extended to 504h post-dose)
The Tmax of Emodepside in Plasma
Time to reach maximum plasma concentration (Tmax) was obtained directly from the concentration-time data
Measured: From pre-dose until 336h post-dose (may be extended to 504h post-dose)
The t½ of Emodepside in Plasma
Terminal half-life (t½), calculated according to the equation t½ = ln2/λz, where λz is the apparent terminal elimination rate constant, estimated by linear regression of log-transformed concentration versus time data
Measured: From pre-dose until 336h post-dose (may be extended to 504h post-dose)
The MRT of Emodepside in Plasma
The mean residence time (MRT) was calculated as MRT = AUMC/AUC∞, where AUMC is the area under the first moment of the concentration-time curve from zero time (pre-dose) extrapolated to infinite time
Measured: From pre-dose until 336h post-dose (may be extended to 504h post-dose)
The CL/F of Emodepside in Plasma
Apparent total clearance from plasma (CL/F) was calculated as CL/F = Dose/AUC∞
Measured: From pre-dose until 336h post-dose (may be extended to 504h post-dose)
The AUC 0-24 of Emodepside in Plasma
Area under the plasma concentration-time curve from time zero (pre-dose) to 24 h was calculated using the trapezoidal method
Measured: From pre-dose until 336h post-dose (may be extended to 504h post-dose)
The AUC 0-24/D of Emodepside in Plasma
Dose-normalized area under the concentration-time curve (AUC) from time zero (pre-dose) to 24 h was calculated as AUC0-24/Dose administered
Measured: From pre-dose until 336h post-dose (may be extended to 504h post-dose)
The AUC 24, Norm of Emodepside in Plasma
Area under the concentration-time curve from time zero (pre-dose) to 24 h, normalized by dose and body weight (AUC 24, norm) was calculated as AUC0-24/(Dose administered*body weight)
Measured: From pre-dose until 336h post-dose (may be extended to 504h post-dose)
The Vz/F of Emodepside in Plasma
Apparent volume of distribution (Vz/F) was calculated as Vz/F = Dose/(λz × AUC∞), where λz is the apparent terminal elimination rate constant, estimated by linear regression of log-transformed concentration versus time data
Measured: From pre-dose until 336h post-dose (may be extended to 504h post-dose)
The AUC Last of Emodepside in Plasma
The area under the concentration-time curve from time zero (pre-dose) to the time of last quantifiable concentration (t), calculated using the linear trapezoidal method for increasing concentrations and the log trapezoidal method for decreasing concentrations
Measured: From pre-dose until 336h post-dose (may be extended to 504h post-dose)
Frel of the IR (Immediate Release) Tablet of Emodepside
The average relative bioavailability (Frel) of the IR tablet was calculated
Measured: From pre-dose until 336h post-dose (may be extended to 504h post-dose)
The AUC Last, Norm of Emodepside in Plasma
The area under the concentration-time curve from time zero (pre-dose) to the time of last quantifiable concentration normalized by dose and body weight (AUClast/(Dose administered*body weight))
Measured: From pre-dose until 336h post-dose (may be extended to 504h post-dose)
Effect of Food on the Bioavailability (Cmax) of Emodepside (BAY 44-4400) After Single Oral Dose Administered as Solution or IR Tablets in One Arm Only
Results of the statistical analysis of the effect of food on Emodepside exposure, after a single dose of 10 mg Emodepside LSF solution.
Measured: From pre-dose until 336h post-dose (may be extended to 504h post-dose)
Effect of Food on the Bioavailability (AUC24) of Emodepside (BAY 44-4400) After Single Oral Dose Administered as Solution or IR Tablets in One Arm Only
Results of the statistical analysis of the effect of food on Emodepside exposure, after a single dose of 10 mg Emodepside LSF solution.
Measured: From pre-dose until 336h post-dose (may be extended to 504h post-dose)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 201527 Mar 2017

First posted22 Jan 2016 (estimated)
Study startDec 2015
Primary completion27 Mar 2017
Study completion27 Mar 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 79 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02661178
Sponsor's protocol ID: DNDI-EMO-001
Other IDs: 2015-003592-29, 2015
Status last verified: Oct 2019
First submitted: 15 Jan 2016
Last updated: 13 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Shin E, Bhat AG, Ramanathan M. Large Language Models for Clinical Trial Protocol Assessments. Clin Pharmacol Ther. 2026 Feb;119(2):393-402. doi: 10.1002/cpt.70096. Epub 2025 Oct 21.
PubMed 41121745

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Blinded, Randomized, Placebo Controlled, Parallel-Group, Single-Dose, Dose-Escalation Study to Investigate Safety, Tolerability, and Pharmacokinetics of Emodepside (BAY 44-4400) After Oral Dosing in Healthy Male Subjects
ClinicalTrials.gov ID: NCT02661178
Acronym / sponsor ID: DNDI-EMO-001
Conditions: Healthy Volunteers
Keywords: Parasitic Diseases, Helminthiasis, Nematode Infections, Secernentea Infections, Spirurida Infections, Filariasis, Skin Diseases, Parasitic, Skin and Connective Tissue Diseases
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 79 participants (actual)
Lead sponsor: Drugs for Neglected DiseasesUniversity, hospital or other
Collaborators: Bayer, Bill and Melinda Gates Foundation
Study start: Dec 2015 (actual)
Primary completion: 27 Mar 2017 (actual)
Study completion: 27 Mar 2017 (actual)
First posted: 22 Jan 2016 (estimated)
Results: Posted 13 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
emodepside (BAY 44-4400)	Experimental	Drug: emodepside (BAY 44-4400)Up to 10 cohorts with single ascending dose
placebo of emodepside (BAY 44-4400)	Placebo comparator	Drug: placeboUp to 10 cohorts with single ascending dose

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Male, Caucasian volunteers, deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine. Optionally, after further evaluation during the study, at the sponsor's discretion other ethnic groups may be recruited.
Aged 18 to 55 years.
With a body mass index (BMI; Quetelet index) in the range of 18 to 30.1 kg/m2 at screening.
Sufficient intelligence to understand the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial.
Willingness to give written consent to participate, after reading the information and consent form, and after having the opportunity to discuss the trial with the investigator or his delegate

Key exclusion criteria (20 listed)

Participation in another clinical trial within 3 months prior and during the study, or 5-times the half-life of the drug tested in the previous clinical trial, whichever is longer (time calculated relative to the last dose in the previous clinical trial)
Clinically relevant abnormal medical history, concurrent medical condition, acute or chronic illness or history of chronic illness sufficient to invalidate the subject's participation in the trial or make it unnecessarily hazardous.
Surgery (eg stomach bypass) or medical condition that might affect absorption of study drug taken orally.
Presence of abnormal physical findings, ECG, or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the subject.
Positive tests for hepatitis B \& C, HIV

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
emodepside (BAY 44-4400)	Drug	emodepside (BAY 44-4400)
placebo	Drug	placebo of emodepside (BAY 44-4400)

Primary outcome

Safety and Tolerability as Measured by Adverse Events
Time frame: Up to 14 days post dose (may be extended to 21 days)
Deaths, serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs)
Safety and Tolerability as Measured by Physical and Neurological Examination Findings
Time frame: Up to 14 days post dose (may be extended to 21 days)
Abnormal or clinically significant neurological examination findings during the study or reported as an AE
Safety and Tolerability as Measured by Vital Signs
Time frame: Up to 14 days post dose (may be extended to 21 days)
Vital signs included heart rate, systolic and diastolic blood pressure,
Safety and Tolerability as Measured by 12-lead ECG
Time frame: Up to 14 days post dose (may be extended to 21 days)
The following variables were recorded in 12-lead ECGs and extracted from continuous 12-lead ECG recordings: ventricular rate, PR interval, QRS interval, QTcB and QTcF interval.
Safety and Tolerability as Measured by Clinical Laboratory Parameters
Time frame: Up to 14 days post dose (may be extended to 21 days)
Clinical laboratory parameters included hematology, biochemistry, serology and coagulation in blood samples and urinalysis in urine samples
Safety and Tolerability as Measured by Ophthalmological Examination Findings in One Study Arm Only
Time frame: Up to 14 days post dose (may be extended to 21 days)
Subjects attended a specialist eye hospital for ophthalmology assessments by a Consultant Ophthalmologist. Opthalmology assessments included:ocular symptoms, past ocular history, auto-refraction, best corrected distance visual acuity, color vision assessment, amsler grid assessment, ocular alignment and ocular motility assessment, confrontation visual field assessment, slit lamp examination (anterior segment), intraocular pressure (Goldmann Tonometry), optical coherence scanning of tomography, post mydriatic ocular media (at Screening visit 2 only) and retinal examination with slit lamp and lens.

18 secondary outcomes

The AUC∞ of Emodepside in Plasma
Time frame: From pre-dose until 336h post-dose (may be extended to 504h post-dose)
The AUC∞/D of Emodepside in Plasma
Time frame: From pre-dose until 336h post-dose (may be extended to 504h post-dose)
The Cmax of Emodepside in Plasma
Time frame: From pre-dose until 336h post-dose (may be extended to 504h post-dose)
The Cmax/D of Emodepside in Plasma
Time frame: From pre-dose until 336h post-dose (may be extended to 504h post-dose)
The Cmax, Norm of Emodepside in Plasma
Time frame: From pre-dose until 336h post-dose (may be extended to 504h post-dose)
The Tmax of Emodepside in Plasma
Time frame: From pre-dose until 336h post-dose (may be extended to 504h post-dose)
The t½ of Emodepside in Plasma
Time frame: From pre-dose until 336h post-dose (may be extended to 504h post-dose)
The MRT of Emodepside in Plasma
Time frame: From pre-dose until 336h post-dose (may be extended to 504h post-dose)
The CL/F of Emodepside in Plasma
Time frame: From pre-dose until 336h post-dose (may be extended to 504h post-dose)
The AUC 0-24 of Emodepside in Plasma
Time frame: From pre-dose until 336h post-dose (may be extended to 504h post-dose)
The AUC 0-24/D of Emodepside in Plasma
Time frame: From pre-dose until 336h post-dose (may be extended to 504h post-dose)
The AUC 24, Norm of Emodepside in Plasma
Time frame: From pre-dose until 336h post-dose (may be extended to 504h post-dose)
The Vz/F of Emodepside in Plasma
Time frame: From pre-dose until 336h post-dose (may be extended to 504h post-dose)
The AUC Last of Emodepside in Plasma
Time frame: From pre-dose until 336h post-dose (may be extended to 504h post-dose)
Frel of the IR (Immediate Release) Tablet of Emodepside
Time frame: From pre-dose until 336h post-dose (may be extended to 504h post-dose)
The AUC Last, Norm of Emodepside in Plasma
Time frame: From pre-dose until 336h post-dose (may be extended to 504h post-dose)
Effect of Food on the Bioavailability (Cmax) of Emodepside (BAY 44-4400) After Single Oral Dose Administered as Solution or IR Tablets in One Arm Only
Time frame: From pre-dose until 336h post-dose (may be extended to 504h post-dose)
Effect of Food on the Bioavailability (AUC24) of Emodepside (BAY 44-4400) After Single Oral Dose Administered as Solution or IR Tablets in One Arm Only
Time frame: From pre-dose until 336h post-dose (may be extended to 504h post-dose)

Results and safety

Results posted to the registry on 13 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Emodepside 0.1mg Solution, Fasted (Part 1)	1	0
Emodepside 1mg Solution, Fasted (Part 1)	5	5
Emodepside 2.5mg Solution, Fasted (Part 1)	6	6
Emodepside 5mg Solution, Fasted (Part 1)	6	6
Emodepside 5mg Tablet, Fasted (Part 1)	5	5
Emodepside 10mg Solution, Fasted (Part 1)	6	6
Emodepside 20mg Solution, Fasted (Part 1)	6	6
Emodepside 20mg Tablet, Fasted (Part 1)	6	6
Emodepside 40mg Solution, Fasted (Part 1)	6	6
Placebo Solution, Fasted (Part 1)	12	12
Placebo Tablet, Fasted (Part 1)	4	4
Emodepside 10mg Solution, Fed (Part 2)	0	0
Emodepside 40mg Solution, Fasted, (Part 2)	0	0
Placebo Solution, Fed (Part 2)	0	0
Placebo Solution, Fasted (Part 2)	0	0

Primary outcome: Safety and Tolerability as Measured by Adverse Events

Time frame: Up to 14 days post dose (may be extended to 21 days). Number. Unit: participants

Measure	Emodepside 0.1mg Solution, Fasted (Part 1) n = 1	Emodepside 1mg Solution, Fasted (Part 1) n = 5	Emodepside 5mg Solution, Fasted (Part 1) n = 6	Emodepside 5mg Tablet, Fasted (Part 1) n = 5	Emodepside 10mg Solution, Fasted (Part 1) n = 6	Emodepside 20mg Solution, Fasted (Part 1) n = 6	Emodepside 20mg Tablet, Fasted (Part 1) n = 6	Emodepside 40mg Solution, Fasted (Part 1) n = 6	Emodepside 10mg Solution, Fed (Part 2) n = 6	Emodepside 40mg Solution, Fasted, (Part 2) n = 6	Placebo Solution, Fasted (Part 1) n = 12	Placebo Tablet, Fasted (Part 1) n = 4
Deaths	0	0	0	0	0	0	0	0	0	0	0	0
Subjects with SAE	0	0	0	0	0	0	0	0	0	0	0	0
Subjects with TEAE	1	3	3	3	5	3	2	5	3	5	5	1

Population analysed: AEs were determined in the Safety Population. In Part 1 n=63 (n=62 subjects completed). One subject in the 1mg emodepside group was withdrawn after receiving 0.1mg emodepside LSF, owing to an AE. He consented to follow-up safety assessment until Day 7 as a 0.1mg emodepside group. In Part 2, n=16 (n=16 subjects completed)

Primary outcome: Safety and Tolerability as Measured by Physical and Neurological Examination Findings

Time frame: Up to 14 days post dose (may be extended to 21 days). Number. Unit: participants

Measure	Emodepside 1mg Solution, Fasted (Part 1) n = 5	Emodepside 2.5mg Solution, Fasted (Part 1) n = 6	Emodepside 5mg Solution, Fasted (Part 1) n = 6	Emodepside 5mg Tablet, Fasted (Part 1) n = 5	Emodepside 10mg Solution, Fasted (Part 1) n = 6	Emodepside 20mg Solution, Fasted (Part 1) n = 6	Emodepside 20mg Tablet, Fasted (Part 1) n = 6	Emodepside 40mg Solution, Fasted (Part 1) n = 6	Emodepside 10mg Solution, Fed (Part 2) n = 6	Emodepside 40mg Solution, Fasted, (Part 2) n = 6	Placebo Solution, Fasted (Part 1) n = 12	Placebo Tablet, Fasted (Part 1) n = 4	Placebo Solution, Fed (Part 2) n = 2	Placebo Solution, Fasted (Part 2) n = 2
Abnormal neurological examination	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Neurological examination reported as AE	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Abnormal physcial examination	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Physical examination reported as AE

Primary outcome: Safety and Tolerability as Measured by Vital Signs

Time frame: Up to 14 days post dose (may be extended to 21 days). Number. Unit: participants

Measure	Emodepside 0.1mg Solution, Fasted (Part 1) n = 1	Emodepside 1mg Solution, Fasted (Part 1) n = 5	Emodepside 2.5mg Solution, Fasted (Part 1) n = 6	Emodepside 5mg Solution, Fasted (Part 1) n = 6	Emodepside 5mg Tablet, Fasted (Part 1) n = 5	Emodepside 10mg Solution, Fasted (Part 1) n = 6	Emodepside 20mg Solution, Fasted (Part 1) n = 6	Emodepside 20mg Tablet, Fasted (Part 1) n = 6	Emodepside 40mg Solution, Fasted (Part 1) n = 6	Emodepside 10mg Solution, Fed (Part 2) n = 6	Emodepside 40mg Solution, Fasted, (Part 2) n = 6	Placebo Solution, Fasted (Part 1) n = 12	Placebo Tablet, Fasted (Part 1) n = 4	Placebo Solution, Fed (Part 2) n = 2	Placebo Solution, Fasted (Part 2) n = 2
Clinically significant change in heart rate	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Clinically significant change in systolic BP	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Clinically significant change in diastolic BP	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Primary outcome: Safety and Tolerability as Measured by 12-lead ECG

Time frame: Up to 14 days post dose (may be extended to 21 days). Number. Unit: participants

Measure	Emodepside 5mg Tablet, Fasted (Part 1) n = 5	Emodepside 10mg Solution, Fasted (Part 1) n = 6	Emodepside 20mg Solution, Fasted (Part 1) n = 6	Emodepside 20mg Tablet, Fasted (Part 1) n = 6	Emodepside 40mg Solution, Fasted (Part 1) n = 6	Emodepside 10mg Solution, Fed (Part 2) n = 6	Emodepside 40mg Solution, Fasted, (Part 2) n = 6	Placebo Solution, Fasted (Part 1) n = 12	Placebo Tablet, Fasted (Part 1) n = 4	Placebo Solution, Fed (Part 2) n = 2	Placebo Solution, Fasted (Part 2) n = 2
Notable changes in ventricular rate	0	0	0	0	0	0	0	0	0	0	0
Notable changes in PR interval	0	0	0	0	0	0	0	0	0	0	0
Notable changes in QRS interval	0	0	0	0	0	0	0	0	0	0	0
Notable changes in QTcB

18 secondary outcomes are reported in the full results.

Adverse events

Time frame: The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Emodepside 0.1mg Solution, Fasted (Part 1)	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Emodepside 1mg Solution, Fasted (Part 1)	0 of 5 (0%)	3 of 5 (60%)	0 of 5
Emodepside 2.5mg Solution, Fasted (Part 1)	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Emodepside 5mg Solution, Fasted (Part 1)	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Emodepside 5mg Tablet, Fasted (Part 1)	0 of 5 (0%)	3 of 5 (60%)	0 of 5
Emodepside 10mg Solution, Fasted (Part 1)	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Emodepside 20mg Solution, Fasted (Part 1)	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Emodepside 20mg Tablet, Fasted (Part 1)	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Emodepside 40mg Solution, Fasted (Part 1)	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Emodepside 10mg Solution, Fed (Part 2)	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Emodepside 40mg Solution, Fasted, (Part 2)	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Placebo Solution, Fasted (Part 1)	0 of 12 (0%)	5 of 12 (41.7%)	0 of 12
Placebo Tablet, Fasted (Part 1)	0 of 4 (0%)	1 of 4 (25%)	0 of 4
Placebo Solution, Fed (Part 2)	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Placebo Solution, Fasted (Part 2)	0 of 2 (0%)	0 of 2 (0%)	0 of 2

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41121745Shin E, Bhat AG, Ramanathan M. Large Language Models for Clinical Trial Protocol Assessments. Clin Pharmacol Ther. 2026 Feb;119(2):393-402. doi: 10.1002/cpt.70096. Epub 2025 Oct 21.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Malcolm Boyce, MD, BSc principal investigator

Hammersmith Medicines Research

Frederic Monnot study director

Drugs for Neglected Diseases initiative

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing emodepside (BAY 44-4400) in people with Healthy Volunteers, run by Drugs for Neglected Diseases at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability as Measured by Adverse Events (time frame: Up to 14 days post dose (may be extended to 21 days)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02661178, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2020.