| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Onchocerciasis | Drug: Moxidectin | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 27 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Sequential Assignment |
| Intervention Model Description: | Prospective, age-stratified, adaptive, open-label, single-dose study with 3, age-defined cohorts. Cohort 1 (12 to 17 years, n = 9) and Cohort 2 (8 to 11 years, n = 9) will receive moxidectin 8 mg. Cohort 3 (4 to 7 years, n = 9) will receive moxidectin at a dose to be determined from safety and pharmacokinetic data analyses of Cohorts 1 and 2. If the starting dose for Cohorts 2 and 3 results in at least 3 subjects with moxidectin exposures above the target range, a revised dose will be determined in decrements of 2 mg and the Cohort(s) will be repeated with at least 9 new subjects. For Cohort 3, if the starting dose results in at least 3 subjects with moxidectin exposures below the target range, a revised dose will be determined in increments of 2 mg to a maximum dose of 8 mg.Therefore, it is expected that the study will enroll 27 subjects. However, if additional cohorts are required to meet pharmacokinetic outcomes, up to a maximum of 63 subjects may be enrolled. |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open-label Study of the Pharmacokinetics and Safety of a Single Dose of Moxidectin Per Oral in Subjects Aged 4 to 17 Years With (or at Risk of) Onchocerciasis to Identify an Optimal Dose for Treatment of Children 4 to 11 Years |
| Actual Study Start Date : | March 29, 2021 |
| Estimated Primary Completion Date : | December 2021 |
| Estimated Study Completion Date : | March 2022 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Cohort 1: 12-17 years
Moxidectin 8mg per oral, single dose
|
Drug: Moxidectin
2 mg tablets
|
|
Experimental: Cohort 2: 8-11 years
Moxidectin 8mg (or lower dose) per oral, single dose
|
Drug: Moxidectin
2 mg tablets
|
|
Experimental: Cohort 3: 4-7 years
Moxidectin single dose, determined by population pharmacokinetic modelling including data from Cohorts 1 and 2
|
Drug: Moxidectin
2 mg tablets
|
| Ages Eligible for Study: | 4 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Aged 4 to 17 years, inclusive:
Exclusion Criteria:
Weight:
Clinically relevant laboratory abnormalities at Screening, including:
| Contact: Sally Kinrade | +6139912 2400 | sally.kinrade@medicinesdevelopment.com | |
| Contact: Melinda Lowe, PhD | +6139912 2400 | melinda.lowe@medicinesdevelopment.com |
| Ghana | |
| University of Health and Allied Services School of Public Health | Recruiting |
| Hohoe, Volta Region, Ghana | |
| Contact: Nicholas O Opoku, MB Ch B, MSc +233 362 722 042 noopoku@uhas.edu.gh | |
| Principal Investigator: Nicholas O Opoku, MB Ch B, MSc | |
| Principal Investigator: | Nicholas O Opoku, MD | University of Health and Allied Sciences School of Public Health, Hohoe, Ghana |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 22, 2019 | ||||||||
| First Posted Date ICMJE | May 23, 2019 | ||||||||
| Last Update Posted Date | May 18, 2021 | ||||||||
| Actual Study Start Date ICMJE | March 29, 2021 | ||||||||
| Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Area under the plasma concentration versus time curve of moxidectin [ Time Frame: Pre-dose to Day 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.
|
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | A Pharmacokinetic and Safety Study of Moxidectin to Identify an Optimal Dose for Treatment of Children 4 to 11 Years | ||||||||
| Official Title ICMJE | An Open-label Study of the Pharmacokinetics and Safety of a Single Dose of Moxidectin Per Oral in Subjects Aged 4 to 17 Years With (or at Risk of) Onchocerciasis to Identify an Optimal Dose for Treatment of Children 4 to 11 Years | ||||||||
| Brief Summary | The primary purpose of this study is to determine a dose of moxidectin for children 4 to 11 years that is equivalent to an 8 mg dose administered for treatment of onchocerciasis in people 12 years and over. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 1 | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Sequential Assignment Intervention Model Description: Prospective, age-stratified, adaptive, open-label, single-dose study with 3, age-defined cohorts. Cohort 1 (12 to 17 years, n = 9) and Cohort 2 (8 to 11 years, n = 9) will receive moxidectin 8 mg. Cohort 3 (4 to 7 years, n = 9) will receive moxidectin at a dose to be determined from safety and pharmacokinetic data analyses of Cohorts 1 and 2. If the starting dose for Cohorts 2 and 3 results in at least 3 subjects with moxidectin exposures above the target range, a revised dose will be determined in decrements of 2 mg and the Cohort(s) will be repeated with at least 9 new subjects. For Cohort 3, if the starting dose results in at least 3 subjects with moxidectin exposures below the target range, a revised dose will be determined in increments of 2 mg to a maximum dose of 8 mg.Therefore, it is expected that the study will enroll 27 subjects. However, if additional cohorts are required to meet pharmacokinetic outcomes, up to a maximum of 63 subjects may be enrolled. Primary Purpose: Treatment |
||||||||
| Condition ICMJE | Onchocerciasis | ||||||||
| Intervention ICMJE | Drug: Moxidectin
2 mg tablets
|
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| Study Arms ICMJE |
|
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
27 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | March 2022 | ||||||||
| Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Sex/Gender ICMJE |
|
||||||||
| Ages ICMJE | 4 Years to 17 Years (Child) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
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| Listed Location Countries ICMJE | Ghana | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03962062 | ||||||||
| Other Study ID Numbers ICMJE | MDGH-MOX-1006 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement ICMJE |
|
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| Responsible Party | Medicines Development for Global Health | ||||||||
| Study Sponsor ICMJE | Medicines Development for Global Health | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
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| PRS Account | Medicines Development for Global Health | ||||||||
| Verification Date | November 2020 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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