The ultimate goal of this process is to achieve accurate and reliable information on long-term efficacy and safety that will support marketing approval and widespread clinical use. The MA Holder shall maintain the capability to furnish all necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work set forth below. The Master Agreement Orders to be issued pursuant to this Master Agreement will fall within the scope of the work described in the Statement of Work. All potential contractors must qualify for both Task I and Task II as described below. To qualify for a MA, applicants shall address all issues and provide all information as outlined below, including a sample protocol for a phase 1 clinical trial of a chemopreventive agent.
Normal volunteers are eligible for single-dose studies.
Approach to the selection of an initial dose, escalation levels, and pharmacokinetic design. Number of subjects at each level. Post prandial and fasted subjects shall be evaluated. It is anticipated that approximately 24 subjects shall be evaluated in the single-dose study. Methods of assessing toxicity.