Phase 1
Completed N=76
Study Investigating the Safety, Tolerability, PK and Food Effect of BEN8744.
Healthy Volunteer Study
Source: ClinicalTrials.gov NCT06118385 ↗
Enrolled (actual)
76
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: Change From Baseline in Observer's Assessment of Alertness/Sedation Scale (OAAS/S) (Part A) — 0; 0; 0; 0 score on a scale (change)
Summary
BEN8744 is an experimental new medicine for treating inflammatory bowel diseases such as Ulcerative Colitis.
The study will test single and repeated oral doses of BEN8744 or placebo. BEN8744 is a first in human study, so will start with a small dose and the dose will be increased as the study progresses. The goal is to find out its side effects and blood levels when taken by mouth and whether food affects the blood levels.
This is a 3-part study (Parts A, B and C) in up to 108 healthy people, aged 18-65.
Part A, will include up to 64 participants, single doses of BEN8744 or placebo. They'll take about 2 weeks to finish the study, stay on the ward for 4 nights and 5 days in a row and make 2 outpatient visits.
Part B, will include up to 12 participants, single doses of BEN8744 with and without food. They'll take up to 3 weeks to finish the study, stay on the ward for 4 nights and 5 days in a row on 2 occasions, and make 2 outpatient visits.
Part C will include up to 32 participants repeat doses of the BEN8744 or placebo for 14 days. They'll take about 4 weeks to complete the study, stay on the ward for 17 nights and 18 days in a row and make 2 outpatient visits.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Observer's Assessment of Alertness/Sedation Scale (OAAS/S) (Part A) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Change From Baseline in Visual Analogue Scale (VAS) (Part A) |
1.8; -3.0; 0.5; 3.7; -1.2; -5.8 | — |
| PRIMARY Cmax (PK Part B) |
76.7; 88.8; 265; 173 | — |
| PRIMARY Tmax (PK Part B) |
1.08; 2.02; 1.00; 3.00 | — |
| PRIMARY AUC24 (PK Part B) |
227; 332; 721; 666 | — |
| PRIMARY AUC72 (PK Part B) |
229; 335; 723; 669 | — |
| PRIMARY AUClast (PK Part B) |
226; 332; 721; 667 | — |
| PRIMARY AUCinf (PK Part B) |
228; 335; 723; 669 | — |
| PRIMARY t1⁄2 (PK Part B) |
4.12; 4.83; 4.23; 3.83 | — |
| PRIMARY Terminal Rate Constant (PK Part B) |
0.210; 0.217; 0.300; 0.340 | — |
| PRIMARY CL/F (PK Part B) |
135; 92.0; 75.1; 82.3 | — |
| PRIMARY VZ/F (PK Part B) |
846; 550; 327; 310 | — |
| PRIMARY %AUCextrap (PK Part B) |
0.991; 0.638; 0.156; 0.198 | — |
| PRIMARY Change From Baseline in Observer's Assessment of Alertness/Sedation Scale (OAAS/S) (Part C) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Change From Baseline in Visual Analogue Scale (VAS) (Part C) |
1.0; 2.2; -0.3; 2.5; 2.7; 1.8 | — |
| PRIMARY Columbia-Suicide Severity Rating Scale (C-SSRS) (Part C) |
4; 6; 6; 4; 6; 6 | — |
| SECONDARY Cmax (PK Part A) |
1.10; 4.20; 43.7; 297; 548; 695 | — |
| SECONDARY Tmax (PK Part A) |
2.00; 1.50; 2.03; 1.00; 2.00; 1.00 | — |
| SECONDARY AUC24 (PK Part A) |
NA; 13.8; 154; 901; 1781; 1949 | — |
| SECONDARY AUC72 (PK Part A) |
NA; 13.9; 155; 904; 1788; 1959 | — |
| SECONDARY AUClast (PK Part A) |
2.56; 12.9; 153; 902; 1786; 1955 | — |
| SECONDARY AUCinf (PK Part A) |
NA; 13.8; 155; 904; 1788; 1959 | — |
| SECONDARY %AUCextrap (PK Part A) |
6.62; 4.95; 0.910; 0.202; 0.0796; 0.108 | — |
| SECONDARY t1⁄2 (PK Part A) |
NA; 1.89; 3.50; 4.51; 5.57; 7.12 | — |
| SECONDARY Terminal Rate Constant (PK Part A) |
NA; 0.419; 0.214; 0.216; 0.221; 0.143 | — |
| SECONDARY CL/F (PK Part A) |
NA; 489; 139; 75.0; 59.4; 66.4 | — |
| SECONDARY VZ/F (PK Part A) |
NA; 1268; 666; 384; 374; 720 | — |
| SECONDARY Change From Baseline in Observer's Assessment of Alertness/Sedation Scale (OAAS/S) (Part B) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Visual Analogue Scale (VAS) (Part B) |
-0.7; 1.7; -3.0; -1.6; 2.3; 8.0 | — |
| SECONDARY Cmax (PK Part C) |
77.9; 198; 49.5; 138; 85.4; 241 | — |
| SECONDARY Tmax (PK Part C) |
2.00; 1.51; 3.03; 3.00; 2.08; 2.00 | — |
| SECONDARY Ctrough (PK Part C) |
0.684; 1.65; 1.81; 3.57; 2.97; 4.68 | — |
| SECONDARY AUCtau (PK Part C) |
210; 521; 231; 540; 254; 792 | — |
| SECONDARY AUClast (PK Part C) |
410; 1034; 270; 831 | — |
| SECONDARY AUC72 (PK Part C) |
273; 837 | — |
| SECONDARY t1⁄2 (PK Part C) |
1.68; 1.63; 5.89; 9.87 | — |
| SECONDARY AUCinf (PK Part C) |
449; 1149; 273; 839 | — |
| SECONDARY %AUCextrap (PK Part C) |
1.36; 0.832; 1.14; 0.921 | — |
| SECONDARY Terminal Rate Constant (PK Part C) |
0.424; 0.428; 0.169; 0.123 | — |
| SECONDARY CLSS/F (PK Part C) |
139; 70.2 | — |
| SECONDARY VZ/F (PK Part C) |
1221; 977 | — |
| SECONDARY Rac(AUCtau) (PK Part C) |
1.33; 1.65 | — |
| SECONDARY Rac(Cmax) (PK Part C) |
1.22; 1.29 | — |
| SECONDARY SR(AUC) (PK Part C) |
0.556; 0.733 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female healthy volunteer in good health
- Aged 18-65 years
- Body mass index 18.0-30.9 and weight ≥ 50 kg
Exclusion Criteria
- Woman who is pregnant or lactating, or pre-menopausal woman who is sexually active and not using a reliable method of contraception
Data sourced from ClinicalTrials.gov (NCT06118385). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.