Table 1.
Number of TEAEs (and percentage of total TEAEs) possibly or probably related to the study drug by preferred term and dose levels/(n = subjects) in the SAD, MAD, and older adult cohorts
| Cohort and MedDRA AE term | Placebo | I (0.2 mg/day) | II (0.6 mg/day) | III (1.0 mg/day) | III (1.5 mg/day) | IV (2.5 mg/day) | V (4.0 mg/day) |
|---|---|---|---|---|---|---|---|
| SAD cohort | n = 10 | n = 6 | n = 6 | n = 0 | n = 6 | n = 6 | n = 6 |
| Diarrhea | 1 (7.7) | ||||||
| Headache | 1 (7.7) | 1 (7.7) | 1 (7.7) | ||||
| Feeling hot | 1 (7.7) | ||||||
| Euphoric mood | 1 (7.7) | 1 (7.7) | |||||
| Musculoskeletal stiffness | 1 (7.7) | ||||||
| Paresthesia | 1 (7.7) | ||||||
| Abdominal discomfort | 1 (7.7) | ||||||
| Dry mouth | 1 (7.7) | ||||||
| Asthenia | 1 (7.7) | ||||||
| Blunted affect | 1 (7.7) | ||||||
| Total 13 (100) | 1 (7.7) | 1 (7.7) | 3 (23.1) | 2 (15.4) | 3 (23.1) | 3 (23.1) |
| MAD cohort | n = 11 | n = 6 | n = 6 | n = 6 | n = 6 | n = 6 | n = 3 |
|---|---|---|---|---|---|---|---|
| Palpitations | 1 (1.6) | ||||||
| Dry mouth | 5 (8.2) | 4 (6.5) | 3 (4.9) | 1 (1.6) | |||
| Asthenia | 2 (3.3) | 2 (3.3) | 1 (1.6) | 1 (1.6) | |||
| Feeling hot | 1 (1.6) | 1(1.6) | |||||
| Muscle spasms | 1(1.6) | ||||||
| Dizziness postural | 2 (3.3) | 1(1.6) | 1 (1.6) | ||||
| Headache | 3 (4.9) | 3 (4.9) | 1 (1.6) | 2 (3.3) | 2 (3.3) | 2 (3.3) | |
| Dyspepsia | 1 (1.6) | ||||||
| Salivary hypersecretion | 1 (1.6) | 1 (1.6) | |||||
| Feeling drunk | 1 (1.6) | ||||||
| Somnolence | 2 (3.3) | 1 (1.6) | |||||
| Apathy | 1 (1.6) | ||||||
| Blunted affect | 2 (3.3) | ||||||
| Euphoric mood | 1 (1.6) | ||||||
| Daydreaming | 1 (1.6) | ||||||
| Diplopia | 1 (1.6) | ||||||
| Vision blurred | 1 (1.6) | ||||||
| Constipation | 1 (1.6) | 1 (1.6) | |||||
| Feeling cold | 3 (4.9) | ||||||
| Nasopharyngitis | 1 (1.6) | ||||||
| Hematoma | 1 (1.6) | ||||||
| Total 61 (100) | 17 (27.9) | 10 (16.4) | 11 (18.0) | 13 (21.3) | 7 (11.5) | 1 (1.6) | 2 (3.3) |
| Elderly cohort | n = 1 | n = 3 | |||||
|---|---|---|---|---|---|---|---|
| Palpitations | 1 (4.8) | ||||||
| Vertigo | 1 (4.8) | 1 (4.8) | |||||
| Diarrhea | 2 (9.5) | ||||||
| Asthenia | 1 (4.8) | ||||||
| Feeling cold | 1 (4.8) | ||||||
| Gait disturbance | 1 (4.8) | ||||||
| Musculoskeletal stiffness | 1 (4.8) | ||||||
| Postural dizziness | 4 (19.0) | ||||||
| Headache | 3 (14.3) | ||||||
| Somnolence | 1 (4.8) | ||||||
| Blunted effect | 2 (9.5) | 1 (4.8) | |||||
| Euphoric mood | 1 (4.8) | ||||||
| Total 21 (100) | 11 (52.4) | 10 (47.6) |
Data are presented as n (%). AEs occurring on the same day are only counted once
AE adverse event, MAD multiple ascending dose, MedDRA Medical Dictionary for Regulatory Activities, SAD single ascending dose, TEAE treatment-emergent adverse event