Ignite Creation Date:
2024-05-06 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06118385
Status:
COMPLETED
Last Update Posted:
2024-04-30
First Post:
2023-09-22
Brief Title:
Study Investigating the Safety Tolerability PK and Food Effect of BEN8744
Sponsor:
BenevolentAI Bio
Organization:
BenevolentAI Bio
Study Overview
Official Title:
A Randomised Double-blind Placebo-controlled Phase 1 First-in-human Study to Investigate the Safety Tolerability Pharmacokinetics and Food Effect of Single- and Multiple-ascending Doses of BEN8744 in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
BEN8744 is an experimental new medicine for treating inflammatory bowel diseases such as Ulcerative Colitis
The study will test single and repeated doses of BEN8744 or placebo by mouth 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 Theyll 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 Theyll 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 Theyll 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
The study will test single and repeated doses of BEN8744 or placebo by mouth 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 Theyll 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 Theyll 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 Theyll 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
Detailed Description:
This first time in human study will investigate the safety tolerability pharmacokinetics PK of BEN8744 after single and multiple ascending oral doses in healthy subjects in both the fed and fasted state The results of this study will be used to select doses for subsequent studies in patients This is an exploratory study in healthy volunteers with no anticipated therapeutic benefit to the participants involvement of patients service users or members of the public in the design of the trial is not appropriate
Primary objectives Part A To assess the safety and tolerability of single ascending oral doses of BEN8744 in healthy subjects Part B To characterise the effect of food on the pharmacokinetic profile of at least 1 dose of BEN8744 Part C To assess the safety and tolerability of multiple ascending oral doses of BEN8744 in healthy subjects
Secondary objectives Part A To assess the PK profile of BEN8744 after single oral doses in healthy subjects Part B To assess the safety and tolerability of a single dose of BEN8744 following high-fat food intake relative to fasting conditions in healthy subjects Part C To assess the PK profile of BEN8744 after repeated oral doses in healthy subjects
Exploratory objective
Part B and optional in Part C
To measure BEN8744 in urine and determine renal clearance in healthy subjects Exploratory characterisation of BEN8744 and its metabolites in plasma urine and faeces
For part A
Up to 64 subjects 5 cohorts 3 optional 6 active 2 placebo
Subjects will receive a single dose of BEN8744 or placebo as capsules after an overnight fast of at least 10 h
At each dose level 6 subjects will receive BEN8744 and 2 will receive matching placebo in an overall ratio of 31
The starting dose for Group 1 is 2 mg BEN8744 or placebo It is intended that subsequent cohorts will receive higher doses The planned doses are
A1- 2mg A2- 6mg A3- 20mg A4- 60mg A5- 100mg A6 optional - 120mg
For Part B
Up to 12 subjects 1 cohorts 1 optional 2 sessions fastedfed
Each subject in Part B will have 2 study sessions Sessions 1 and 2 in which they will receive a single dose of BEN8744 by mouth
Each subject will receive BEN8744 after an overnight fast of at least 10 h in one session and after an FDA high-fat breakfast 1013 kcal 592 g fat of which 281 g saturated fat in the other session the order will be randomised 11
A subjects doses will be separated by a washout of at least 7 days or 5 half-lives as determined in Part A whichever is longer
Subjects dosed on the same day may be dosed at intervals of at least 10 min
For Part C
Up 32 subjects 3 cohorts 1 optional 6 active 2 placebo
Each subject will receive daily doses of BEN8744 or placebo by mouth for 14 days
Doses will be taken once or twice daily in the fasted state unless emerging data indicate they should be taken in the fed state
Part C will not start until at least 3 dose levels have been completed in Part A and may also be conducted in parallel with Part B
Primary objectives Part A To assess the safety and tolerability of single ascending oral doses of BEN8744 in healthy subjects Part B To characterise the effect of food on the pharmacokinetic profile of at least 1 dose of BEN8744 Part C To assess the safety and tolerability of multiple ascending oral doses of BEN8744 in healthy subjects
Secondary objectives Part A To assess the PK profile of BEN8744 after single oral doses in healthy subjects Part B To assess the safety and tolerability of a single dose of BEN8744 following high-fat food intake relative to fasting conditions in healthy subjects Part C To assess the PK profile of BEN8744 after repeated oral doses in healthy subjects
Exploratory objective
Part B and optional in Part C
To measure BEN8744 in urine and determine renal clearance in healthy subjects Exploratory characterisation of BEN8744 and its metabolites in plasma urine and faeces
For part A
Up to 64 subjects 5 cohorts 3 optional 6 active 2 placebo
Subjects will receive a single dose of BEN8744 or placebo as capsules after an overnight fast of at least 10 h
At each dose level 6 subjects will receive BEN8744 and 2 will receive matching placebo in an overall ratio of 31
The starting dose for Group 1 is 2 mg BEN8744 or placebo It is intended that subsequent cohorts will receive higher doses The planned doses are
A1- 2mg A2- 6mg A3- 20mg A4- 60mg A5- 100mg A6 optional - 120mg
For Part B
Up to 12 subjects 1 cohorts 1 optional 2 sessions fastedfed
Each subject in Part B will have 2 study sessions Sessions 1 and 2 in which they will receive a single dose of BEN8744 by mouth
Each subject will receive BEN8744 after an overnight fast of at least 10 h in one session and after an FDA high-fat breakfast 1013 kcal 592 g fat of which 281 g saturated fat in the other session the order will be randomised 11
A subjects doses will be separated by a washout of at least 7 days or 5 half-lives as determined in Part A whichever is longer
Subjects dosed on the same day may be dosed at intervals of at least 10 min
For Part C
Up 32 subjects 3 cohorts 1 optional 6 active 2 placebo
Each subject will receive daily doses of BEN8744 or placebo by mouth for 14 days
Doses will be taken once or twice daily in the fasted state unless emerging data indicate they should be taken in the fed state
Part C will not start until at least 3 dose levels have been completed in Part A and may also be conducted in parallel with Part B
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None