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PURPOSE OF STUDY PT 988S73 (E-77/78)
SC-19192: 115 Week Oral Tumorigenicity Study in the Rat
According to the submission to FDA, this study was intended to evaluate the safety and tumorigenic potential of SC-19192, diketopiperazine (5-benzyl-3, 6-dioxo-2-piperazine-acetic acid), which is a conversion product of aspartame, and to induce and define such adverse effects as might occur only at prodigious multiples of the estimated daily human intake. The commercial grade of aspartame (SC-18862) may contain up to 2 percent of the conversion product (DKP), according to Searle's specifications.
DATES
Study e-77/78 (PT #988S73) was initiated on November 8, l971. The study was to be terminated at 104 weeks, but was extended to 115 weeks. The reason for extending the study was stated as follows in protocol amendment #3 dated September 6, l973: "it was decided to extend or continue the study until the mortality of either sex reduced the control group to 20 animals per sex, provided the survival in the treated groups is not less than 10 animals/sex/treated group prior to that period. This approach is consistent with current FDA desires." A copy of the study protocol is attached as exhibit #11.
Initiation of treatment was staggered over a two week period as follows: | 
