Report on an informal meeting assessing the feasibility of initiating the first Phase II study of moxidectin tablets in subjects infected with Onchocerca volvulus
Summary
WHO convened an informal meeting in Accra, Ghana to assess the feasibility of initiating the first study of moxidectin tablets in subjects infected with Onchocerca volvulus. The meeting was convened in the context of the post-marketing experiences in the United States of America (USA) with an injectable six month sustained-release formulation of moxidectin (ProHeart®6) for the prevention of heartworm in dogs. Participants included three international experts in onchocerciasis control; representatives of the Ghana regulatory and ethical review authorities, and the head of the Onchocerciasis Chemotherapy Research Centre in Ghana (the designated principal investigator for the first study of moxidectin tablets in subjects infected with Onchocerca volvulus).
The following data were reviewed and discussed in depth in the context of the draft protocol for the study: 1) all data on ProHeart®6 that had been made available to the FDA-Center for Veterinary Medicine Advisory Committee on ProHeart®6; 2) the results of moxidectin toxicology studies; and 3) the safety data from two healthy volunteer (Phase I) studies carried out in the UK and Germany in 2001 and 2003. Following review and discussion, the participants recommended unanimously that the planned first study of moxidectin tablets in subjects infected with Onchocerca volvulus (Phase II) should be initiated as soon as possible.
Annex 2 - Meeting documents
Documents provided to participants ahead of the meeting
1. Draft agenda [PDF: 30Kb, 2 pages]
Introduction, background, objectives of the meeting [PDF: 173Kb, 3 pages]
2. a. Investigator brochure, April 2004
Section 1 [PDF: 2.9Mb, 9 pages]
Section 2 [PDF: 825Kb, 2 pages]
Section 3 [PDF:466Kb, 2 pages]
Section 4 [PDF: 3.5Mb, 11 pages]
Section 5 [PDF: 6.9Mb, 19 pages]
Section 6 [PDF: 5.6Mb, 20 pages]
Section 7 [PDF: 1.4Mb, 4 pages]
Section 8 [PDF:3.2Mb, 16 pages]
Section 9 [PDF: 2.7Mb, 8 pages]
b. IB safety attachment [PDF: 54Kb, 13 pages]
3. Summary of safety relevant animal and human data generated since April 2004 and source documents: [PDF: 90Kb, 5 pages]
a. Wyeth review of safety data from human volunteer studies, November 2004:
Alain Patat, Moxidectin human safety evaluation of studies 100 and 101 [PDF: 144Kb, 18 pages]
b. Report on moxidectin pharmacokinetics after of a single dose of 10 mg of liquid or tablet formulation [PDF: 394Kb, 94 pages]
4. Summary of data related to ProHeart®6 and source documents [PDF: 360Kb, 19 pages]
a. FDA-CVM briefing package for FDA Veterinary Medicines Advisory Committee (FDA VMAC) [PDF: 1Mb, 72 pages]
b. FDA-CVM presentations at FDA VMAC (document 2) [PDF: 328Kb, 36 pages] - [PDF: 317Kb, 28 pages]
c. Fort Dodge Animal Health (FDAH) briefing package for FDA VMAC [PDF: 1Mb, 99 pages]
d. FDAH presentations at FDA VMAC (document 3) [PDF: 88Kb, 15 pages] - [PDF: 435Kb, 20 pages] - [PDF: 115Kb, 30 pages]
5. Protocol for OCRC study in patients with onchocerciasis [PDF: 672Kb, 108 pages]
6. Link of OCRC study in patients with onchocerciasis to other clinical studies [PDF: 1Kb, 28 pages]