Trial Outcomes & Findings for A Pharmacokinetic and Safety Study of Moxidectin to Identify an Optimal Dose for Treatment of Children 4 to 11 Years (NCT NCT03962062)
NCT ID: NCT03962062
Last Updated: 2025-09-05
Results Overview
Moxidectin concentration in plasma collected at pre-specified intervals after dosing with oral moxidectin determined using a validated liquid chromatography-mass spectrometry(MS)/MS method.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
Pre-dose (Screening) and post-dose at Hours 1, 2, 4, 8, 24 and 72 and Days 7, 14 and 28.
Results posted on
2025-09-05
Participant Flow
The first participant was screened on 29 March 2021 and the last participant last study visit was completed on 28 September 2022. Participants were recruited from communities in the Kpassa sub-district of the Oti region in Ghana, which is endemic for onchocerciasis.
Participant milestones
| Measure |
12 to 17 Years MOX 8 mg
Cohort 1: Nine (9) participants aged 12 to 17 years at Screening received a single oral dose of moxidectin 8 mg and were followed for 24 weeks for pharmacokinetic and safety outcomes.
|
8 to 11 Years MOX 8 mg
Cohort 2: Nine (9) participants aged 8 to 11 years at Screening received a single oral dose of moxidectin 8 mg and were followed for 24 weeks for pharmacokinetic and safety outcomes.
|
8 to 11 Years MOX 6 mg
Cohort 2: Nine (9) participants aged 8 to 11 years at Screening received a single oral dose of moxidectin 6 mg and were followed for 24 weeks for pharmacokinetic and safety outcomes.
|
4 to 7 Years MOX 4 mg
Cohort 3: Nine (9) participants aged 4 to 7 years at Screening received a single oral dose of moxidectin 4 mg and were followed for 24 weeks for pharmacokinetic and safety outcomes.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
9
|
9
|
|
Overall Study
COMPLETED
|
9
|
9
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pharmacokinetic and Safety Study of Moxidectin to Identify an Optimal Dose for Treatment of Children 4 to 11 Years
Baseline characteristics by cohort
| Measure |
12 to 17 Years Moxidectin 8 mg
n=9 Participants
Cohort 1: Nine (9) participants aged 12 to 17 years at Screening received a single oral dose of moxidectin 8 mg and were followed for 24 weeks for pharmacokinetic and safety outcomes.
|
8 to 11 Years Moxidectin 6 mg
n=9 Participants
Cohort 2: Nine (9) participants aged 8 to 11 years at Screening received a single oral dose of moxidectin 6 mg and were followed for 24 weeks for pharmacokinetic and safety outcomes.
|
8 to 11 Years Moxidectin 8 mg
n=9 Participants
Cohort 2: Nine (9) participants aged 8 to 11 years at Screening received a single oral dose of moxidectin 8 mg and were followed for 24 weeks for pharmacokinetic and safety outcomes.
|
4 to 7 Years Moxidectin 4 mg
n=9 Participants
Cohort 3: Nine (9) participants aged 4 to 7 years at Screening received a single oral dose of moxidectin 4 mg and were followed for 24 weeks for pharmacokinetic and safety outcomes.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
13.7 years
STANDARD_DEVIATION 1.66 • n=5 Participants
|
9.1 years
STANDARD_DEVIATION 1.05 • n=7 Participants
|
9.7 years
STANDARD_DEVIATION 0.87 • n=5 Participants
|
5.4 years
STANDARD_DEVIATION 1.33 • n=4 Participants
|
9.5 years
STANDARD_DEVIATION 3.19 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Ghana
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
9 participants
n=5 Participants
|
9 participants
n=4 Participants
|
36 participants
n=21 Participants
|
|
Height
|
149.74 cm
STANDARD_DEVIATION 10.318 • n=5 Participants
|
130.09 cm
STANDARD_DEVIATION 9.307 • n=7 Participants
|
133.11 cm
STANDARD_DEVIATION 10.590 • n=5 Participants
|
108.81 cm
STANDARD_DEVIATION 7.922 • n=4 Participants
|
130.44 cm
STANDARD_DEVIATION 17.381 • n=21 Participants
|
|
Weight
|
39.42 kg
STANDARD_DEVIATION 8.754 • n=5 Participants
|
25.89 kg
STANDARD_DEVIATION 4.567 • n=7 Participants
|
27.13 kg
STANDARD_DEVIATION 4.844 • n=5 Participants
|
16.90 kg
STANDARD_DEVIATION 2.662 • n=4 Participants
|
27.34 kg
STANDARD_DEVIATION 9.766 • n=21 Participants
|
|
BMI
|
17.39 kg/m2
STANDARD_DEVIATION 1.745 • n=5 Participants
|
15.19 kg/m2
STANDARD_DEVIATION 1.068 • n=7 Participants
|
15.23 kg/m2
STANDARD_DEVIATION 1.120 • n=5 Participants
|
14.20 kg/m2
STANDARD_DEVIATION 0.919 • n=4 Participants
|
15.50 kg/m2
STANDARD_DEVIATION 1.683 • n=21 Participants
|
|
Mean upper arm circumference at Screening
|
21.78 cm
STANDARD_DEVIATION 2.065 • n=5 Participants
|
18.42 cm
STANDARD_DEVIATION 0.981 • n=7 Participants
|
18.66 cm
STANDARD_DEVIATION 1.591 • n=5 Participants
|
15.68 cm
STANDARD_DEVIATION 1.347 • n=4 Participants
|
18.63 cm
STANDARD_DEVIATION 2.644 • n=21 Participants
|
PRIMARY outcome
Timeframe: Pre-dose (Screening) and post-dose at Hours 1, 2, 4, 8, 24 and 72 and Days 7, 14 and 28.Population: The Pharmacokinetic Analysis Set included all participants who received moxidectin and provided a minimum number of plasma samples for the determination of Pharmacokinetic (PK) parameters, defined as one (1) sample taken at each of hours 4, 24 and 72, plus one (1) sample taken at either Day 14 or Day 28. Subjects were analyzed according to the dose received.
Moxidectin concentration in plasma collected at pre-specified intervals after dosing with oral moxidectin determined using a validated liquid chromatography-mass spectrometry(MS)/MS method.
Outcome measures
| Measure |
12 to 17 Years MOX 8 mg
n=9 Participants
Cohort 1: Nine (9) participants aged 12 to 17 years at Screening received a single oral dose of moxidectin 8 mg and were followed for 24 weeks for pharmacokinetic and safety outcomes.
|
8 to 11 Years MOX 6 mg
n=9 Participants
Cohort 2: Nine (9) participants aged 8 to 11 years at Screening received a single oral dose of moxidectin 6 mg and were followed for 24 weeks for pharmacokinetic and safety outcomes.
|
8 to 11 Years MOX 8 mg
n=9 Participants
Cohort 2: Nine (9) participants aged 8 to 11 years at Screening received a single oral dose of moxidectin 8 mg and were followed for 24 weeks for pharmacokinetic and safety outcomes.
|
4 to 7 Years MOX 4 mg
n=9 Participants
Cohort 3: Nine (9) participants aged 4 to 7 years at Screening received a single oral dose of moxidectin 4 mg and were followed for 24 weeks for pharmacokinetic and safety outcomes.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve of Moxidectin.
|
2680 (hr*ng/mL)/mg
Geometric Coefficient of Variation 24.7
|
2230 (hr*ng/mL)/mg
Geometric Coefficient of Variation 52.3
|
3310 (hr*ng/mL)/mg
Geometric Coefficient of Variation 23.0
|
1880 (hr*ng/mL)/mg
Geometric Coefficient of Variation 26.5
|
SECONDARY outcome
Timeframe: Pre-dose (Screening) and post-dose at Hours 1, 2, 4, 8, 24 and 72, Days 7, 14 and 28 and Week 12.Population: The Pharmacokinetic Analysis Set included all participants who received moxidectin and provided a minimum number of plasma samples for the determination of PK parameters, defined as one (1) sample taken at each of hours 4, 24 and 72, plus one (1) sample taken at either Day 14 or Day 28. Subjects were analyzed according to the dose received.
Moxidectin concentration in plasma collected at pre-specified intervals after dosing with oral moxidectin determined using a validated liquid chromatography-mass spectrometry(MS)/MS method.
Outcome measures
| Measure |
12 to 17 Years MOX 8 mg
n=8 Participants
Cohort 1: Nine (9) participants aged 12 to 17 years at Screening received a single oral dose of moxidectin 8 mg and were followed for 24 weeks for pharmacokinetic and safety outcomes.
|
8 to 11 Years MOX 6 mg
n=9 Participants
Cohort 2: Nine (9) participants aged 8 to 11 years at Screening received a single oral dose of moxidectin 6 mg and were followed for 24 weeks for pharmacokinetic and safety outcomes.
|
8 to 11 Years MOX 8 mg
n=9 Participants
Cohort 2: Nine (9) participants aged 8 to 11 years at Screening received a single oral dose of moxidectin 8 mg and were followed for 24 weeks for pharmacokinetic and safety outcomes.
|
4 to 7 Years MOX 4 mg
n=9 Participants
Cohort 3: Nine (9) participants aged 4 to 7 years at Screening received a single oral dose of moxidectin 4 mg and were followed for 24 weeks for pharmacokinetic and safety outcomes.
|
|---|---|---|---|---|
|
Area Under the Concentration Versus Time Curve (Zero to Infinity) of Moxidectin
|
3140 (hr*ng/mL)/mg
Geometric Coefficient of Variation 24.8
|
2490 (hr*ng/mL)/mg
Geometric Coefficient of Variation 59.2
|
3780 (hr*ng/mL)/mg
Geometric Coefficient of Variation 29.2
|
2000 (hr*ng/mL)/mg
Geometric Coefficient of Variation 29.3
|
SECONDARY outcome
Timeframe: Pre-dose (Screening) and post-dose at Hours 1, 2, 4 and 8.Population: The Pharmacokinetic Analysis Set included all participants who received moxidectin and provided a minimum number of plasma samples for the determination of PK parameters, defined as one (1) sample taken at each of hours 4, 24 and 72, plus one (1) sample taken at either Day 14 or Day 28. Subjects were analyzed according to the dose received.
Moxidectin concentration in plasma collected at pre-specified intervals after dosing with oral moxidectin determined using a validated liquid chromatography-mass spectrometry(MS)/MS method.
Outcome measures
| Measure |
12 to 17 Years MOX 8 mg
n=9 Participants
Cohort 1: Nine (9) participants aged 12 to 17 years at Screening received a single oral dose of moxidectin 8 mg and were followed for 24 weeks for pharmacokinetic and safety outcomes.
|
8 to 11 Years MOX 6 mg
n=9 Participants
Cohort 2: Nine (9) participants aged 8 to 11 years at Screening received a single oral dose of moxidectin 6 mg and were followed for 24 weeks for pharmacokinetic and safety outcomes.
|
8 to 11 Years MOX 8 mg
n=9 Participants
Cohort 2: Nine (9) participants aged 8 to 11 years at Screening received a single oral dose of moxidectin 8 mg and were followed for 24 weeks for pharmacokinetic and safety outcomes.
|
4 to 7 Years MOX 4 mg
n=9 Participants
Cohort 3: Nine (9) participants aged 4 to 7 years at Screening received a single oral dose of moxidectin 4 mg and were followed for 24 weeks for pharmacokinetic and safety outcomes.
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentrations (Cmax) of Moxidectin
|
83.1 ng/mL
Geometric Coefficient of Variation 19.1
|
82.1 ng/mL
Geometric Coefficient of Variation 41.2
|
115 ng/mL
Geometric Coefficient of Variation 25.6
|
86.4 ng/mL
Geometric Coefficient of Variation 28.3
|
SECONDARY outcome
Timeframe: Day 0 to Week 24 inclusive.Population: The Safety Analysis Set included all participants who received any exposure to moxidectin. Subjects were analyzed according to the dose received.
Incidence and severity of adverse events, assessed by the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Paediatric Adverse Events, Version 2.1.
Outcome measures
| Measure |
12 to 17 Years MOX 8 mg
n=9 Participants
Cohort 1: Nine (9) participants aged 12 to 17 years at Screening received a single oral dose of moxidectin 8 mg and were followed for 24 weeks for pharmacokinetic and safety outcomes.
|
8 to 11 Years MOX 6 mg
n=9 Participants
Cohort 2: Nine (9) participants aged 8 to 11 years at Screening received a single oral dose of moxidectin 6 mg and were followed for 24 weeks for pharmacokinetic and safety outcomes.
|
8 to 11 Years MOX 8 mg
n=9 Participants
Cohort 2: Nine (9) participants aged 8 to 11 years at Screening received a single oral dose of moxidectin 8 mg and were followed for 24 weeks for pharmacokinetic and safety outcomes.
|
4 to 7 Years MOX 4 mg
n=9 Participants
Cohort 3: Nine (9) participants aged 4 to 7 years at Screening received a single oral dose of moxidectin 4 mg and were followed for 24 weeks for pharmacokinetic and safety outcomes.
|
|---|---|---|---|---|
|
Incidence and Severity of Adverse Events.
TEAEs by Severity Grade 1 Mild
|
3 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Incidence and Severity of Adverse Events.
Grade 2 Moderate
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Incidence and Severity of Adverse Events.
Grade 3 Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence and Severity of Adverse Events.
All Treatment-emergent Adverse Events (TEAEs)
|
4 Participants
|
7 Participants
|
6 Participants
|
7 Participants
|
|
Incidence and Severity of Adverse Events.
Grade 4 Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
12 to 17 Years MOX 8 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
8 to 11 Years MOX 6 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
8 to 11 Years MOX 8 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
4 to 7 Years MOX 4 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Overall
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
12 to 17 Years MOX 8 mg
n=9 participants at risk
Cohort 1: Nine (9) participants aged 12 to 17 years at Screening received a single oral dose of moxidectin 8 mg and were followed for 24 weeks for pharmacokinetic and safety outcomes.
|
8 to 11 Years MOX 6 mg
n=9 participants at risk
Cohort 2: Nine (9) participants aged 8 to 11 years at Screening received a single oral dose of moxidectin 6 mg and were followed for 24 weeks for pharmacokinetic and safety outcomes.
|
8 to 11 Years MOX 8 mg
n=9 participants at risk
Cohort 2: Nine (9) participants aged 8 to 11 years at Screening received a single oral dose of moxidectin 8 mg and were followed for 24 weeks for pharmacokinetic and safety outcomes.
|
4 to 7 Years MOX 4 mg
n=9 participants at risk
Cohort 3: Nine (9) participants aged 4 to 7 years at Screening received a single oral dose of moxidectin 4 mg and were followed for 24 weeks for pharmacokinetic and safety outcomes.
|
Overall
n=36 participants at risk
Combined Cohorts 1 to 3: 36 participants
|
|---|---|---|---|---|---|
|
Infections and infestations
Malaria
|
11.1%
1/9 • Number of events 1 • Day 0 to 24 weeks.
|
55.6%
5/9 • Number of events 7 • Day 0 to 24 weeks.
|
44.4%
4/9 • Number of events 6 • Day 0 to 24 weeks.
|
44.4%
4/9 • Number of events 6 • Day 0 to 24 weeks.
|
38.9%
14/36 • Number of events 20 • Day 0 to 24 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.1%
1/9 • Number of events 1 • Day 0 to 24 weeks.
|
11.1%
1/9 • Number of events 1 • Day 0 to 24 weeks.
|
11.1%
1/9 • Number of events 1 • Day 0 to 24 weeks.
|
0.00%
0/9 • Day 0 to 24 weeks.
|
8.3%
3/36 • Number of events 3 • Day 0 to 24 weeks.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/9 • Day 0 to 24 weeks.
|
11.1%
1/9 • Number of events 1 • Day 0 to 24 weeks.
|
11.1%
1/9 • Number of events 1 • Day 0 to 24 weeks.
|
0.00%
0/9 • Day 0 to 24 weeks.
|
5.6%
2/36 • Number of events 2 • Day 0 to 24 weeks.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/9 • Day 0 to 24 weeks.
|
0.00%
0/9 • Day 0 to 24 weeks.
|
0.00%
0/9 • Day 0 to 24 weeks.
|
11.1%
1/9 • Number of events 1 • Day 0 to 24 weeks.
|
2.8%
1/36 • Number of events 1 • Day 0 to 24 weeks.
|
|
Infections and infestations
Hookworm infection
|
0.00%
0/9 • Day 0 to 24 weeks.
|
0.00%
0/9 • Day 0 to 24 weeks.
|
0.00%
0/9 • Day 0 to 24 weeks.
|
11.1%
1/9 • Number of events 1 • Day 0 to 24 weeks.
|
2.8%
1/36 • Number of events 1 • Day 0 to 24 weeks.
|
|
Infections and infestations
Tinea versicolour
|
11.1%
1/9 • Number of events 1 • Day 0 to 24 weeks.
|
0.00%
0/9 • Day 0 to 24 weeks.
|
0.00%
0/9 • Day 0 to 24 weeks.
|
0.00%
0/9 • Day 0 to 24 weeks.
|
2.8%
1/36 • Number of events 1 • Day 0 to 24 weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • Day 0 to 24 weeks.
|
0.00%
0/9 • Day 0 to 24 weeks.
|
22.2%
2/9 • Number of events 2 • Day 0 to 24 weeks.
|
11.1%
1/9 • Number of events 1 • Day 0 to 24 weeks.
|
8.3%
3/36 • Number of events 3 • Day 0 to 24 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9 • Day 0 to 24 weeks.
|
22.2%
2/9 • Number of events 2 • Day 0 to 24 weeks.
|
0.00%
0/9 • Day 0 to 24 weeks.
|
11.1%
1/9 • Number of events 1 • Day 0 to 24 weeks.
|
8.3%
3/36 • Number of events 3 • Day 0 to 24 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • Day 0 to 24 weeks.
|
0.00%
0/9 • Day 0 to 24 weeks.
|
0.00%
0/9 • Day 0 to 24 weeks.
|
11.1%
1/9 • Number of events 1 • Day 0 to 24 weeks.
|
2.8%
1/36 • Number of events 1 • Day 0 to 24 weeks.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/9 • Day 0 to 24 weeks.
|
0.00%
0/9 • Day 0 to 24 weeks.
|
0.00%
0/9 • Day 0 to 24 weeks.
|
11.1%
1/9 • Number of events 1 • Day 0 to 24 weeks.
|
2.8%
1/36 • Number of events 1 • Day 0 to 24 weeks.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/9 • Day 0 to 24 weeks.
|
0.00%
0/9 • Day 0 to 24 weeks.
|
0.00%
0/9 • Day 0 to 24 weeks.
|
11.1%
1/9 • Number of events 1 • Day 0 to 24 weeks.
|
2.8%
1/36 • Number of events 1 • Day 0 to 24 weeks.
|
|
Investigations
False positive investigation result
|
0.00%
0/9 • Day 0 to 24 weeks.
|
0.00%
0/9 • Day 0 to 24 weeks.
|
0.00%
0/9 • Day 0 to 24 weeks.
|
11.1%
1/9 • Number of events 1 • Day 0 to 24 weeks.
|
2.8%
1/36 • Number of events 1 • Day 0 to 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
11.1%
1/9 • Number of events 1 • Day 0 to 24 weeks.
|
0.00%
0/9 • Day 0 to 24 weeks.
|
0.00%
0/9 • Day 0 to 24 weeks.
|
0.00%
0/9 • Day 0 to 24 weeks.
|
2.8%
1/36 • Number of events 1 • Day 0 to 24 weeks.
|
Additional Information
Sally Kinrade, Vice President, Project Leader, Onchocerciasis & Lymphatic Filariasis
Medicines Development for Global Health
Phone: +61 3 9912 2400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place