TABLE 3.
Summary of adverse events.
| Adverse event | SAD/Adult | SAD elderly (Part A) | MAD | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| System organ class (SOC) | Preferred term (PT) | TRC150094 5-400 mg n (%) | Placebo | TRC150094 | Placebo | TRC150094 | Placebo (N = 7) n (%) | ||||||||
| 5a mg (N = 6) | 25b mg (N = 6) | 50c mg (N = 6) | 100a mg (N = 6) | 200b mg (N = 6) | 400c mg (N = 6) | All (N = 36) | (N = 12) n (%) | 50 mg (N = 12) | 150 mg (N = 12) | (N = 8) n (%) | 50 mg (N = 12) n (%) | 150 mg (N = 9) n (%) | |||
| No. of subjects reporting at least one AEs post-treatment | 0 | 1 (16.7) | 2 (33.3) | 1 (16.7) | 2 (33.3) | 1 (16.7) | 7 (19.4) | 1 (8.3) | 3 (25.0) | 0 | 0 | 0 | 1 (11.1) | 1 (14.3) | |
| Metabolism and Nutrition | Decreased Appetite | 0 | 0 | 0 | 0 | 1 (16.7) | 1 (16.7) | 2 (5.6) | 1 (8.3) | 0 | 0 | 0 | 0 | 0 | 0 |
| Musculoskeletal and Connective Tissue Disorders | Back Pain | 0 | 0 | 0 | 0 | 0 | 1 (16.7) | 1 (2.8) | 1 (8.3) | 1 (8.3) | 0 | 0 | 0 | 0 | 0 |
| Myalgia | 0 | 0 | 1 (16.7) | 0 | 0 | 0 | 1 (2.8) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Pain in Extremity | 0 | 0 | 0 | 0 | 1 (16.7) | 1 (16.7) | 2 (5.6) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Nervous System Disorders | Dizziness Postural | 0 | 1 (16.7) | 0 | 1 (16.7) | 0 | 0 | 2 (5.6) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Headache | 0 | 0 | 1 (16.7) | 0 | 1 (16.7) | 1 (16.7) | 3 (8.3) | 0 | 1 (8.3) | 0 | 0 | 0 | 0 | 0 | |
| General disorders and administration site conditions | Pyrexia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (11.1) | 0 |
| Respiratory, thoracic, and mediastinal disorders | Cough | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (14.3) |
N=Number of subjects with non-missing values; n/% = Number/percentage of subjects with the given characteristics.
Cohort 1 received 2 dose levels, 5 and 100 mg, separated by a washout period of 7 days.
Cohort 2 received 2 dose levels, 25 and 200 mg, separated by a washout period of 7 days.
Cohort 3 received 2 dose levels, 50 and 400 mg, separated by a washout period of 7 days.
Abbreviation: SAD, single ascending dose; MAD, multiple ascending doses.