Demographic information of participants included in Stage 1 and in Stage 2, randomized to receive an oral administration of BTZ-043
| Variable (unit) . | Stage 1 . | Stage 2 . | Combined Stage 1 + 2 . |
|---|---|---|---|
| Total participants, n | 24 | 44 | 68 |
| Age (years), median (range) | 26 (20–57) | 27 (18–56) | 27 (18–57) |
| Weight (kg), median (range) | 55 (47–81) | 53 (42–71) | 54 (42–81) |
| Height (m), median (range) | 1.7 (1.5–1.9) | 1.7 (1.6–1.9) | 1.7 (1.5–1.9) |
| Male sex, n (%) | 17 (71) | 40 (90) | 57 (84) |
| HIV-1 negative, n (%) | 24 (100) | 44 (100) | 68 (100) |
| Self-identified race, n (%) | |||
| Black | 15 (63) | 29 (66) | 44 (65) |
| Cape-coloured | 8 (33) | 15 (34) | 23 (34) |
| White | 1 (4) | 0 (0) | 1 (1) |
| Fooda, n (%) | |||
| Fasted | 24 (100) | 0 (0) | 24 |
| High-fat | 19 (100) | 0 (0) | 19 |
| Standard together with dose | 0 (0) | 24 | 24 |
| Standard 30 min prior to dose | 0 (0) | 20 | 20 |
| Variable (unit) . | Stage 1 . | Stage 2 . | Combined Stage 1 + 2 . |
|---|---|---|---|
| Total participants, n | 24 | 44 | 68 |
| Age (years), median (range) | 26 (20–57) | 27 (18–56) | 27 (18–57) |
| Weight (kg), median (range) | 55 (47–81) | 53 (42–71) | 54 (42–81) |
| Height (m), median (range) | 1.7 (1.5–1.9) | 1.7 (1.6–1.9) | 1.7 (1.5–1.9) |
| Male sex, n (%) | 17 (71) | 40 (90) | 57 (84) |
| HIV-1 negative, n (%) | 24 (100) | 44 (100) | 68 (100) |
| Self-identified race, n (%) | |||
| Black | 15 (63) | 29 (66) | 44 (65) |
| Cape-coloured | 8 (33) | 15 (34) | 23 (34) |
| White | 1 (4) | 0 (0) | 1 (1) |
| Fooda, n (%) | |||
| Fasted | 24 (100) | 0 (0) | 24 |
| High-fat | 19 (100) | 0 (0) | 19 |
| Standard together with dose | 0 (0) | 24 | 24 |
| Standard 30 min prior to dose | 0 (0) | 20 | 20 |
aParticipants in Stage 1 had BTZ-043 while fasting on Days 1–11 and with a high-fat meal on Day 14.
Demographic information of participants included in Stage 1 and in Stage 2, randomized to receive an oral administration of BTZ-043
| Variable (unit) . | Stage 1 . | Stage 2 . | Combined Stage 1 + 2 . |
|---|---|---|---|
| Total participants, n | 24 | 44 | 68 |
| Age (years), median (range) | 26 (20–57) | 27 (18–56) | 27 (18–57) |
| Weight (kg), median (range) | 55 (47–81) | 53 (42–71) | 54 (42–81) |
| Height (m), median (range) | 1.7 (1.5–1.9) | 1.7 (1.6–1.9) | 1.7 (1.5–1.9) |
| Male sex, n (%) | 17 (71) | 40 (90) | 57 (84) |
| HIV-1 negative, n (%) | 24 (100) | 44 (100) | 68 (100) |
| Self-identified race, n (%) | |||
| Black | 15 (63) | 29 (66) | 44 (65) |
| Cape-coloured | 8 (33) | 15 (34) | 23 (34) |
| White | 1 (4) | 0 (0) | 1 (1) |
| Fooda, n (%) | |||
| Fasted | 24 (100) | 0 (0) | 24 |
| High-fat | 19 (100) | 0 (0) | 19 |
| Standard together with dose | 0 (0) | 24 | 24 |
| Standard 30 min prior to dose | 0 (0) | 20 | 20 |
| Variable (unit) . | Stage 1 . | Stage 2 . | Combined Stage 1 + 2 . |
|---|---|---|---|
| Total participants, n | 24 | 44 | 68 |
| Age (years), median (range) | 26 (20–57) | 27 (18–56) | 27 (18–57) |
| Weight (kg), median (range) | 55 (47–81) | 53 (42–71) | 54 (42–81) |
| Height (m), median (range) | 1.7 (1.5–1.9) | 1.7 (1.6–1.9) | 1.7 (1.5–1.9) |
| Male sex, n (%) | 17 (71) | 40 (90) | 57 (84) |
| HIV-1 negative, n (%) | 24 (100) | 44 (100) | 68 (100) |
| Self-identified race, n (%) | |||
| Black | 15 (63) | 29 (66) | 44 (65) |
| Cape-coloured | 8 (33) | 15 (34) | 23 (34) |
| White | 1 (4) | 0 (0) | 1 (1) |
| Fooda, n (%) | |||
| Fasted | 24 (100) | 0 (0) | 24 |
| High-fat | 19 (100) | 0 (0) | 19 |
| Standard together with dose | 0 (0) | 24 | 24 |
| Standard 30 min prior to dose | 0 (0) | 20 | 20 |
aParticipants in Stage 1 had BTZ-043 while fasting on Days 1–11 and with a high-fat meal on Day 14.
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