Safety and Tolerability Study of Acoziborole in g-HAT Ser... | NCT05256017

Label	Type	Description	Intervention Names
Acoziborole	Experimental	Single dose administration of acoziborole, 3 tablets of 320 mg	Drug: Acoziborole
Placebo	Placebo Comparator	Single dose administration of acoziborole matching placebo, 3 tablets of 320 mg	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Acoziborole	Drug	Single dose administration of acoziborole (3 tablets of 320 mg) on Day 1	Acoziborole

Measure	Description	Time Frame
Occurrence of Any TEAEs	Occurrence and excess rate (95% CI) of any TEAEs.	From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).
Occurrence of TEAEs - Malaria	Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).	From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).
Occurrence of TEAEs - Acarodermatitis	Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).	From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).
Occurrence of TEAEs - Abdominal Pain	Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).	From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).
Occurrence of TEAEs - Enteritis	Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).	From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).
Occurrence of TEAEs - Nausea	Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).	From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).

Measure	Description	Time Frame
Occurrence of Adverse Events (AEs)	Occurrence of any Adverse Event from Inform Consent signature to 4 month follow-up visit. Of note, all AEs reported during this study were TEAEs.	From Inform Consent signature (up to 2 days before treatment) to the Month 4 follow up visit (End of Study)
Change From Baseline in Biochemistry Parameter: Alanine Aminotransferase

Name	Affiliation	Role
Victor Kande Betu Kumeso, Dr.	Ministry of Public Health, Hygiene and Prevention, Kinshasa	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
General Referral Hospital of Bagata		Bagata	Bandundu		Democratic Republic of the Congo
Hospital of Dipumba

ID	Title	Description
FG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
FG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 13, 2023	Feb 6, 2025

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Occurrence of Any TEAEs

Occurrence and excess rate (95% CI) of any TEAEs.

Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Posted

Count of Participants

Participants

From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000906 OG001300

Title

Denominators

Categories

Title	Measurements
	OG000195 OG00169

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Excess rate (ER)	-1.5			2-Sided	95	-7.2	3.7					Other

Primary

Occurrence of TEAEs - Malaria

Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).

Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Posted

Count of Participants

Participants

From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Primary

Occurrence of TEAEs - Acarodermatitis

Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).

Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Posted

Count of Participants

Participants

From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Primary

Occurrence of TEAEs - Abdominal Pain

Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).

Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Posted

Count of Participants

Participants

From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Primary

Occurrence of TEAEs - Enteritis

Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).

Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Posted

Count of Participants

Participants

From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Primary

Occurrence of TEAEs - Nausea

Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).

Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Posted

Count of Participants

Participants

From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Primary

Occurrence of TEAEs - Gastritis

Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).

Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Posted

Count of Participants

Participants

From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Primary

Occurrence of TEAEs - Headache

Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).

Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Posted

Count of Participants

Participants

From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Primary

Occurrence of TEAEs - Fatigue

Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).

Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Posted

Count of Participants

Participants

From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Primary

Occurrence of TEAEs - Blood Potassium Increased

Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).

Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Posted

Count of Participants

Participants

From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Primary

Occurrence of TEAEs by Period of Occurrence

Occurrence and excess rate (95% CI) of any TEAEs, by period of occurrence.

Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Posted

Number

participants

During hospitalization: from investigational product administration (Day 1) to Day 5 (End of Hospitalization); After hospitalization: from Day 5 (discharge) to the Month 4 follow-up visit (End of Study).

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Primary

Occurrence of Serious TEAEs

Occurrence and excess rate (95% CI) of any serious TEAEs.

Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Posted

Count of Participants

Participants

From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Secondary

Occurrence of Adverse Events (AEs)

Occurrence of any Adverse Event from Inform Consent signature to 4 month follow-up visit.

Of note, all AEs reported during this study were TEAEs.

Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Posted

Count of Participants

Participants

From Inform Consent signature (up to 2 days before treatment) to the Month 4 follow up visit (End of Study)

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Biochemistry Parameter: Alanine Aminotransferase

Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.

Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Posted

Mean

Standard Deviation

U/L

From baseline to the Month 4 follow-up visit (End of Study).

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Biochemistry Parameter: Albumin

Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.

Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Posted

Mean

Standard Deviation

g/dL

From baseline to the Month 4 follow-up visit (End of Study).

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Biochemistry Parameter: Alkaline Phosphatase

Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.

Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Posted

Mean

Standard Deviation

U/L

From baseline to the Month 4 follow-up visit (End of Study).

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Biochemistry Parameter: Aspartate Aminotransferase

Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.

Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Posted

Mean

Standard Deviation

U/L

From baseline to the Month 4 follow-up visit (End of Study).

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Biochemistry Parameter: Calcium

Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.

Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Posted

Mean

Standard Deviation

mmol/L

From baseline to the Month 4 follow-up visit (End of Study).

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Biochemistry Parameter: Chloride

Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.

Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Posted

Mean

Standard Deviation

mmol/L

From baseline to the Month 4 follow-up visit (End of Study).

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Biochemistry Parameter: Creatinine

Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.

Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Posted

Mean

Standard Deviation

mg/dL

From baseline to the Month 4 follow-up visit (End of Study).

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Biochemistry Parameter: Glucose

Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.

Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Posted

Mean

Standard Deviation

mg/dL

From baseline to the Month 4 follow-up visit (End of Study).

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Biochemistry Parameter: Potassium

Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.

Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Posted

Mean

Standard Deviation

mmol/L

From baseline to the Month 4 follow-up visit (End of Study).

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Biochemistry Parameter: Sodium

Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.

Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Posted

Mean

Standard Deviation

mmol/L

From baseline to the Month 4 follow-up visit (End of Study).

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Biochemistry Parameter: Total Bilirubin

Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.

Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Posted

Mean

Standard Deviation

mg/dL

From baseline to the Month 4 follow-up visit (End of Study).

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Biochemistry Parameter: Bicarbonate

Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.

Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Posted

Mean

Standard Deviation

mmol/L

From baseline to the Month 4 follow-up visit (End of Study).

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Biochemistry Parameter: Total Protein

Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.

Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Posted

Mean

Standard Deviation

g/dL

From baseline to the Month 4 follow-up visit (End of Study).

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Biochemistry Parameter: Blood Urea Nitrogen

Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.

Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Posted

Mean

Standard Deviation

mg/dL

From baseline to the Month 4 follow-up visit (End of Study).

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Hematology Parameter: Hemoglobin

Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.

Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Posted

Mean

Standard Deviation

g/dL

From baseline to the Month 4 follow-up visit (End of Study).

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Hematology Parameter: Platelet Count

Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.

Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Posted

Mean

Standard Deviation

10^9 platelets/L

From baseline to the Month 4 follow-up visit (End of Study).

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Hematology Parameter: Leukocytes

Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.

Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Posted

Mean

Standard Deviation

10^9 Leukocytes/L

From baseline to the Month 4 follow-up visit (End of Study).

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Secondary

Change From Baseline in ECG (Electrocardiogram) Parameter: Heart Rate (HR)

Actual values at baseline (Day 1 pre-dose) and Day 5. Change from baseline at Day 5 (Δ). Placebo-corrected change from baseline (ΔΔ), calculated using an analysis of covariance (ANCOVA) model adjusted for sex and age.

ECG central tendency set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data) and who had valid ECG evaluations.

Posted

Mean

Standard Deviation

beats/min

From baseline (Day 1 pre-dose) to Day 5 (End of Hospitalization)

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Secondary

Change From Baseline in ECG Parameter: RR Interval

Actual values at baseline (Day 1 pre-dose) and Day 5. Change from baseline at Day 5 (Δ). Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.

Posted

Mean

Standard Deviation

From baseline (Day 1 pre-dose) to Day 5 (End of Hospitalization)

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Secondary

Change From Baseline in ECG Parameter: PR Interval

Actual values at baseline (Day 1 pre-dose) and Day 5. Change from baseline at Day 5 (Δ). Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.

Posted

Mean

Standard Deviation

From baseline (Day 1 pre-dose) to Day 5 (End of Hospitalization)

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Secondary

Change From Baseline in ECG Parameter: QRS Interval

Actual values at baseline (Day 1 pre-dose) and Day 5. Change from baseline at Day 5 (Δ). Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusting for sex and age.

Posted

Mean

Standard Deviation

From baseline (Day 1 pre-dose) to Day 5 (End of Hospitalization)

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Secondary

Change From Baseline in ECG Parameter: QT Interval

Actual values at baseline (Day 1 pre-dose) and Day 5. Change from baseline at Day 5 (Δ). Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.

Posted

Mean

Standard Deviation

From baseline (Day 1 pre-dose) to Day 5 (End of Hospitalization)

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Secondary

Change From Baseline in ECG Parameter: QTcF

Actual values at baseline (Day 1 pre-dose) and Day 5. Change from baseline at Day 5 (Δ). Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.

Posted

Mean

Standard Deviation

From baseline (Day 1 pre-dose) to Day 5 (End of Hospitalization)

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Secondary

Change From Baseline in ECG Parameter: QTcB

Actual values at baseline (Day 1 pre-dose) and Day 5. Change from baseline at Day 5 (Δ). Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.

Posted

Mean

Standard Deviation

From baseline (Day 1 pre-dose) to Day 5 (End of Hospitalization)

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Secondary

Placebo-corrected Baseline-adjusted QTcF (ΔΔQTcF), Computed From a Concentration-response (C-R) Model Between Dry Blood Spot Concentration and Changes From Baseline in QTcF Parameter

Mixed linear model developed based on the model defined by Garnett et al (2017).

The fixed effect parameters of the pre-specified model were intercept, slope for acoziborole concentrations, influence of baseline (centered on mean), and a treatment specific intercept (0=acoziborole, 1=Placebo). Sex and age were included in the model as fixed covariates.

C-R analysis set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data), who had valid ECG evaluations, and at least one change from baseline in ECG matching a PK sample.

Posted

Mean

90% Confidence Interval

From baseline (Day 1 pre-dose) to Day 5 (End of Hospitalization)

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Secondary

Incidence of Abnormal Values for PR, QRS, QTcB and QTcF According to Pre-defined Thresholds

Incidence of abnormal values for PR, QRS, QTcB and QTcF at Day 1 and/or Day 5, according to pre-defined thresholds

ECG categorical analyses set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data) and who had valid ECG evaluations at Day 1 or Day 5.

Posted

Count of Participants

Participants

From baseline (Day 1 pre-dose) to Day 5 (End of Hospitalization)

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Primary

Occurrence of Severe Treatment-related TEAEs

Occurrence and excess rate (95% CI) of any serious TEAEs.

Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Posted

Count of Participants

Participants

From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Primary

Occurrence of Any Treatment-related TEAEs

Occurrence of any treatment-related TEAEs by arm

Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Posted

Count of Participants

Participants

From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Primary

Occurrence of Treatment-related TEAEs by PT

Occurrence of any treatment-related TEAEs by PT and by arm

Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Posted

Count of Participants

Participants

From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).

ID	Title	Description
OG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
OG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg

Units	Counts
Participants	OG000

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Appendicitis	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected906 at risk EG0011 events1 affected300 at risk
Malaria	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected906 at risk EG0011 events1 affected300 at risk
Wound infection	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected906 at risk EG0011 events1 affected300 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected906 at risk EG0010 events0 affected300 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected906 at risk EG0010 events0 affected300 at risk
Abortion	Pregnancy, puerperium and perinatal conditions	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected906 at risk EG0010 events0 affected300 at risk
Abortion induced	Surgical and medical procedures	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected906 at risk EG0011 events1 affected300 at risk

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Headache	Nervous system disorders	MedDRA (24.0)	Systematic Assessment	EG00054 events53 affected906 at risk EG0019 events8 affected300 at risk
Malaria	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG00035 events34 affected906 at risk EG00113 events13 affected300 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG00023 events23 affected906 at risk EG00110 events9 affected300 at risk
Fatigue	General disorders	MedDRA (24.0)	Systematic Assessment	EG00014 events14 affected906 at risk EG0015 events5 affected300 at risk
Acarodermatitis	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG00013 events13 affected906 at risk EG0013 events3 affected300 at risk
Blood potassium increased	Investigations	MedDRA (24.0)	Systematic Assessment	EG0008 events8 affected906 at risk EG0017 events6 affected300 at risk
Enteritis	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0007 events7 affected906 at risk EG0014 events4 affected300 at risk
Nausea	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0007 events7 affected906 at risk EG0013 events3 affected300 at risk
Gastritis	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0006 events6 affected906 at risk EG0013 events3 affected300 at risk

ID	Term
D014353	Trypanosomiasis, African
D007239	Infections

ID	Term
D014352	Trypanosomiasis
D056986	Euglenozoa Infections
D011528	Protozoan Infections
D010272	Parasitic Diseases
D000079426	Vector Borne Diseases

ID	Title	Description
BG000	Acoziborole	Acoziborole: 3 tablets of 320 mg
BG001	Placebo	Placebo: 3 tablets of 320 mg
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Acoziborole	Acoziborole: 3 tablets of 320 mg	0	906	3	906	137	906
EG001	Placebo	Acoziborole matching placebo: 3 tablets of 320 mg	1	300	4	300	45	300