Trial · NCT03962062
A Pharmacokinetic and Safety Study of Moxidectin to Identify an Optimal Dose for Treatment of Children 4 to 11 Years
NCT03962062, Phase 1, Completed, Medicines Development for Global Health; results first posted 2025-01-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Pharmacokinetic and Safety Study of Moxidectin to Identify an Optimal Dose for Treatment of Children 4 to 11 Years. Trials, record NCT03962062. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03962062
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Pharmacokinetic and Safety Study of Moxidectin to Identify an Optimal Dose for Treatment of Children 4 to 11 Years
- NCT number
- NCT03962062
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 36 participants, actual
- Lead sponsor
- Medicines Development for Global Health
- Conditions
- Onchocerciasis
- Interventions
- Moxidectin
- First posted
- 2019-05-23
- Last updated
- 2025-09-05
- Results first posted
- 2025-01-22
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under the Plasma Concentration Versus Time Curve of Moxidectin. | Pre-dose (Screening) and post-dose at Hours 1, 2, 4, 8, 24 and 72 and Days 7, 14 and 28. | 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. |
| Secondary | Area Under the Concentration Versus Time Curve (Zero to Infinity) of Moxidectin | Pre-dose (Screening) and post-dose at Hours 1, 2, 4, 8, 24 and 72, Days 7, 14 and 28 and Week 12. | 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. |
| Secondary | Maximum Observed Plasma Concentrations (Cmax) of Moxidectin | Pre-dose (Screening) and post-dose at Hours 1, 2, 4 and 8. | 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. |
| Secondary | Incidence and Severity of Adverse Events. | Day 0 to Week 24 inclusive. | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Plasma Concentration Versus Time Curve of Moxidectin. | Pre-dose (Screening) and post-dose at Hours 1, 2, 4, 8, 24 and 72 and Days 7, 14 and 28. | 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. | (hr*ng/mL)/mg | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Concentration Versus Time Curve (Zero to Infinity) of Moxidectin | Pre-dose (Screening) and post-dose at Hours 1, 2, 4, 8, 24 and 72, Days 7, 14 and 28 and Week 12. | 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. | (hr*ng/mL)/mg | GEOMETRIC_MEAN |
| SECONDARY | Maximum Observed Plasma Concentrations (Cmax) of Moxidectin | Pre-dose (Screening) and post-dose at Hours 1, 2, 4 and 8. | 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. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Incidence and Severity of Adverse Events. | Day 0 to Week 24 inclusive. | The Safety Analysis Set included all participants who received any exposure to moxidectin. Subjects were analyzed according to the dose received. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under the Plasma Concentration Versus Time Curve of Moxidectin. | 12 to 17 Years MOX 8 mg | 2680 | Geometric Coefficient of Variation 24.7 | (hr*ng/mL)/mg | |
| Area Under the Plasma Concentration Versus Time Curve of Moxidectin. | 8 to 11 Years MOX 6 mg | 2230 | Geometric Coefficient of Variation 52.3 | (hr*ng/mL)/mg | |
| Area Under the Plasma Concentration Versus Time Curve of Moxidectin. | 8 to 11 Years MOX 8 mg | 3310 | Geometric Coefficient of Variation 23.0 | (hr*ng/mL)/mg | |
| Area Under the Plasma Concentration Versus Time Curve of Moxidectin. | 4 to 7 Years MOX 4 mg | 1880 | Geometric Coefficient of Variation 26.5 | (hr*ng/mL)/mg | |
| Area Under the Concentration Versus Time Curve (Zero to Infinity) of Moxidectin | 12 to 17 Years MOX 8 mg | 3140 | Geometric Coefficient of Variation 24.8 | (hr*ng/mL)/mg | |
| Area Under the Concentration Versus Time Curve (Zero to Infinity) of Moxidectin | 8 to 11 Years MOX 6 mg | 2490 | Geometric Coefficient of Variation 59.2 | (hr*ng/mL)/mg | |
| Area Under the Concentration Versus Time Curve (Zero to Infinity) of Moxidectin | 8 to 11 Years MOX 8 mg | 3780 | Geometric Coefficient of Variation 29.2 | (hr*ng/mL)/mg | |
| Area Under the Concentration Versus Time Curve (Zero to Infinity) of Moxidectin | 4 to 7 Years MOX 4 mg | 2000 | Geometric Coefficient of Variation 29.3 | (hr*ng/mL)/mg | |
| Maximum Observed Plasma Concentrations (Cmax) of Moxidectin | 12 to 17 Years MOX 8 mg | 83.1 | Geometric Coefficient of Variation 19.1 | ng/mL | |
| Maximum Observed Plasma Concentrations (Cmax) of Moxidectin | 8 to 11 Years MOX 6 mg | 82.1 | Geometric Coefficient of Variation 41.2 | ng/mL |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 12 to 17 Years MOX 8 mg | 9 | |
| Overall Study | STARTED | 8 to 11 Years MOX 8 mg | 9 | |
| Overall Study | STARTED | 8 to 11 Years MOX 6 mg | 9 | |
| Overall Study | STARTED | 4 to 7 Years MOX 4 mg | 9 | |
| Overall Study | COMPLETED | 12 to 17 Years MOX 8 mg | 9 | |
| Overall Study | COMPLETED | 8 to 11 Years MOX 8 mg | 9 | |
| Overall Study | COMPLETED | 8 to 11 Years MOX 6 mg | 9 | |
| Overall Study | COMPLETED | 4 to 7 Years MOX 4 mg | 9 | |
| Overall Study | NOT COMPLETED | 12 to 17 Years MOX 8 mg | 0 | |
| Overall Study | NOT COMPLETED | 8 to 11 Years MOX 8 mg | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events65
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Malaria | Infections and infestations | 12 to 17 Years MOX 8 mg | 1 | 9 | 1 |
| other | Malaria | Infections and infestations | 8 to 11 Years MOX 6 mg | 5 | 9 | 7 |
| other | Malaria | Infections and infestations | 8 to 11 Years MOX 8 mg | 4 | 9 | 6 |
| other | Malaria | Infections and infestations | 4 to 7 Years MOX 4 mg | 4 | 9 | 6 |
| other | Malaria | Infections and infestations | Overall | 14 | 36 | 20 |
| other | Upper respiratory tract infection | Infections and infestations | 12 to 17 Years MOX 8 mg | 1 | 9 | 1 |
| other | Upper respiratory tract infection | Infections and infestations | 8 to 11 Years MOX 6 mg | 1 | 9 | 1 |
| other | Upper respiratory tract infection | Infections and infestations | 8 to 11 Years MOX 8 mg | 1 | 9 | 1 |
| other | Upper respiratory tract infection | Infections and infestations | 4 to 7 Years MOX 4 mg | 0 | 9 | 0 |
| other | Upper respiratory tract infection | Infections and infestations | Overall | 3 | 36 | 3 |
1 to 10 of 65Source ClinicalTrials.gov
See all 65 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 12 to 17 Years MOX 8 mg | 0 | 9 |
| Total, all-cause mortality | 8 to 11 Years MOX 6 mg | 0 | 9 |
| Total, all-cause mortality | 8 to 11 Years MOX 8 mg | 0 | 9 |
| Total, all-cause mortality | 4 to 7 Years MOX 4 mg | 0 | 9 |
| Total, all-cause mortality | Overall | 0 | 36 |
| Total, other adverse events | 12 to 17 Years MOX 8 mg | 4 | 9 |
| Total, other adverse events | 8 to 11 Years MOX 6 mg | 7 | 9 |
| Total, other adverse events | 8 to 11 Years MOX 8 mg | 6 | 9 |
| Total, other adverse events | 4 to 7 Years MOX 4 mg | 7 | 9 |
| Total, other adverse events | Overall | 24 | 36 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40707999 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03962062
GET https://conductscience.org/api/trials/v1/NCT03962062/results?page=2