Sample 58

NCT: NCT02730169 Model: local-longctx-7b RAG: no_rag
Deleted (in GT only) Added (in prediction only) Unchanged

Ground Truth

Inclusion Criteria:Adult male subject aged 18 to 65 years inclusiveBMI > 30 kg/m2 and < 50 kg/m2Serum total testosterone concentration below the normal rangeLH levels below the upper limit of normalOestradiol levels within or above the normal range of approved assayAt least two symptoms of androgen deficiency present for at least 2 months prior to the first Screening Visit, with at least one of these being a sexual dysfunctionExclusion Criteria:Evidence of clinically significant endocrinopathy at screening that may interfere with the study assessmentsOther types of hypogonadotropic hypogonadism or primary hypogonadismAny other pituitary or hypothalamic disease

Prediction

Week 21).
Pre-dose and 1h post-dose.
Visit 10 (Week 24).
Pre-dose and 1h post-dose.
Visit 11 (Week 24).
Pre-dose and 1h post-dose.
Visit 12 (Week 24).
Pre-dose and 1h post-dose.
Visit 13 (FU Visit 8).
Pre-dose and 1h post-dose.
Visit 14 (FU Visit 10).
Pre-dose and 1h post-dose.
Visit 15 (FU Visit 12).
Pre-dose and 1h post-dose.
Visit 16 (FU Visit 16).
Pre-dose and 1h post-dose.
Visit 17 (FU Visit 18).
Pre-dose and 1h post-dose.
Visit 18 (FU Visit 20).
Pre-dose and 1h post-dose.
Visit 19 (FU Visit 22).
Pre-dose and 1h post-dose.
Visit 20 (FU Visit 24).
Pre-dose and 1h post-dose.
Visit 21 (EOT).
Pre-dose and 1h post-dose.
11.4.1 PK Parameters Assessed Plasma concentrations of BGS649 will be measured using standardised methods.
The primary PK parameters are: 1.
Total plasma concentration 2.
Bioavailable testosterone (BhT) 3.
Percentage unchanged plasma (PUP) 4.
Percentage unchanged serum (PUS) 5.
Percentage unchanged plasma and serum (PUPS) 6.
Percentage unchanged serum (PUS) 7.
Percentage unchanged plasma (PUP) 8.
Percentage unchanged plasma and serum (PUPS) 9.
Percentage unchanged serum (PUS) 10.
Percentage unchanged plasma (PUP) 11.
Percentage unchanged plasma and serum (PUPS) 12.
Percentage unchanged serum (PUS) 13.
Percentage unchanged plasma (PUP) 13.
Percentage unchanged plasma and serum (PUPS) 14.
Percentage unchanged serum (PUS) 15.
Percentage unchanged plasma (PUP) 16.
Percentage unchanged plasma and serum (PUPS) 17.
Percentage unchanged serum (PUS) 17.
Percentage unchanged plasma (PUP) 18.
Percentage unchanged plasma and serum (PUPS) 19.
Percentage unchanged serum (PUS) 20.
Percentage unchanged plasma (PUP) 21.
Percentage unchanged plasma and serum (PUPS) 22.
Percentage unchanged serum (PUS) 23.
Percentage unchanged plasma (PUP) 24.
Percentage unchanged plasma and serum (PUPS) 25.
Percentage unchanged serum (PUS) 26.
Percentage unchanged plasma (PUP) 27.
Percentage unchanged plasma and serum (PUPS) 28.
Percentage unchanged serum (PUS) 29.
Percentage unchanged plasma (PUP) 30.
Percentage unchanged plasma and serum (PUPS) 31.
Percentage unchanged serum (PUS) 32.
Percentage unchanged plasma (PUP) 33.
Percentage unchanged plasma and serum (PUPS) 34.
Percentage unchanged serum (PUS) 35.
Percentage unchanged plasma (PUP) 36.
Percentage unchanged plasma and serum (PUPS) 37.
Percentage unchanged serum (PUS) 38.
Percentage unchanged plasma (PUP) 39.
Percentage unchanged plasma and serum (PUPS) 40.
Percentage unchanged serum (PUS) 41.
Percentage unchanged plasma (PUP) 42.
Percentage unchanged plasma and serum (PUPS) 43.
Percentage unchanged serum (PUS) 44.
Percentage unchanged plasma (PUP) 45.
Percentage unchanged plasma and serum (PUPS) 46.
Percentage unchanged serum (PUS) 47.
Percentage unchanged plasma (PUP) 48.
Percentage unchanged plasma and serum (PUPS) 49.
Percentage unchanged serum (PUS) 50.
Percentage unchanged plasma (PUP) 51.
Percentage unchanged plasma and serum (PUPS) 52.
Percentage unchanged serum (PUS) 53.
Percentage unchanged plasma (PUP) 54.
Percentage unchanged plasma and serum (PUPS) 55.
Percentage unchanged serum (PUS) 56.
Percentage unchanged plasma (PUP) 57.
Percentage unchanged plasma and serum (PUPS) 58.
Percentage unchanged serum (PUS) 59.
Percentage unchanged plasma (PUP) 60.
Percentage unchanged plasma and serum (PUPS) 61.
Percentage unchanged serum (PUS) 62.
Percentage unchanged plasma (PUP) 63.
Percentage unchanged plasma and serum (PUPS) 64.
Percentage unchanged serum (PUS) 65.
Percentage unchanged plasma (PUP) 66.
Percentage unchanged plasma and serum (PUPS) 67.
Percentage unchanged serum (PUS) 68.
Percentage unchanged plasma (PUP) 69.
Percentage unchanged plasma and serum (PUPS) 70.
Percentage unchanged serum (PUS) 71.
Percentage unchanged plasma (PUP) 72.
Percentage unchanged plasma and serum (PUPS) 73.
Percentage unchanged serum (PUS) 74.
Percentage unchanged plasma (PUP) 75.
Percentage unchanged plasma and serum (PUPS) 76.
Percentage unchanged serum (PUS) 77.
Percentage unchanged plasma (PUP) 78.
Percentage unchanged plasma and serum (PUPS) 79.
Percentage unchanged serum (PUS) 80.
Percentage unchanged plasma (PUP) 81.
Percentage unchanged plasma and serum (PUPS) 82.
Percentage unchanged serum (PUS) 83.
Percentage unchanged plasma (PUP) 84.
Percentage unchanged plasma and serum (PUPS) 85.
Percentage unchanged serum (PUS) 86.
Percentage unchanged plasma (PUP) 87.
Percentage unchanged plasma and serum (PUPS) 88.
Percentage unchanged serum (PUS) 89.
Percentage unchanged plasma (PUP) 90.
Percentage unchanged plasma and serum (PUPS) 91.
Percentage unchanged serum (PUS) 92.
Percentage unchanged plasma (PUP) 93.
Percentage unchanged plasma and serum (PUPS) 94.
Percentage unchanged serum (PUS) 95.
Percentage unchanged plasma (PUP) 96.
Percentage unchanged plasma and serum (PUPS) 97.
Percentage unchanged serum (PUS) 98.
Percentage unchanged plasma (PUP) 99.
Percentage unchanged plasma and serum (PUPS) 100.
Percentage unchanged serum (PUS) 101.
Percentage unchanged plasma (PUP) 102.
Percentage unchanged plasma and serum (PUPS) 103.
Percentage unchanged serum (PUS) 104.
Percentage unchanged plasma (PUP) 105.
Percentage unchanged plasma and serum (PUPS) 106.
Percentage unchanged serum (PUS) 107.
Percentage unchanged plasma (PUP) 108.
Percentage unchanged plasma and serum (PUPS) 109.
Percentage unchanged serum (PUS) 1010.
Percentage unchanged plasma (PUP) 1011.
Percentage unchanged plasma and serum (PUPS) 1012.
Percentage unchanged serum (PUS) 1013.
Percentage unchanged plasma (PUP) 1014.
Percentage unchanged plasma and serum (PUPS) 1015.
Percentage unchanged serum (PUS) 1016.
Percentage unchanged plasma (PUP) 1017.
Percentage unchanged plasma and serum (PUPS) 1018.
Percentage unchanged serum (PUS) 1019.
Percentage unchanged plasma (PUP) 1020.
Percentage unchanged plasma and serum (PUPS) 1021.
Percentage unchanged serum (PUS) 1022.
Percentage unchanged plasma (PUP) 1023.
Percentage unchanged plasma and serum (PUPS) 1024.
Percentage unchanged serum (PUS) 1025.
Percentage unchanged plasma (PUP) 1026.
Percentage unchanged plasma and serum (PUPS) 1027.
Percentage unchanged serum (PUS) 1028.
Percentage unchanged plasma (PUP) 1029.
Percentage unchanged plasma and serum (PUPS) 1030.
Percentage unchanged serum (PUS) 1031.
Percentage unchanged plasma (PUP) 1032.
Percentage unchanged plasma and serum (PUPS) 1033.
Percentage unchanged serum (PUS) 1034.
Percentage unchanged plasma (PUP) 1035.
Percentage unchanged plasma and serum (PUPS) 1036.
Percentage unchanged serum (PUS) 1037.
Percentage unchanged plasma (PUP) 1038.
Percentage unchanged plasma and serum (PUPS) 1039.
Percentage unchanged serum (PUS) 1040.
Percentage unchanged plasma (PUP) 1041.
Percentage unchanged plasma and serum (PUPS) 1042.
Percentage unchanged serum (PUS)
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