Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2026-01-01 @ 7:05 PM
Study NCT ID:
NCT03443895
Status:
COMPLETED
Last Update Posted:
2018-06-19
First Post:
2017-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multiple Ascending Dose to Study the Safety, Tolerability, PK and PD Effects of AEF0117
Sponsor:
Aelis Farma
Organization:
Study Overview
Official Title:
A Phase 1, Single Center, Double-blind, Placebo-Controlled, Dose Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Effects of Multiple Oral Doses of AEF0117 in Healthy Male and Female Subjects
Status:
COMPLETED
Status Verified Date:
2018-06
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:
The study is designated to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of escalating multiple oral doses of AEF0117 in healthy adult male and female subjects.
Detailed Description:
The overall goal of this protocol is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of escalating multiple oral doses of AEF0117. This will be a single center study in healthy male and female subjects. The study design will be a double-blind, randomized, placebo-controlled, single period, parallel group, multiple dose escalation with AEF0117.
Three dose levels are planned for the study with 8 subjects (6 active and 2 placebo) per dose level:
Dose Level I - 0.6 mg multiple oral dose of AEF0117 given on the morning of Day 1 to Day 7 Dose Level II - 2 mg multiple oral dose of AEF0117 given on the morning of Day 1 to Day 7 Dose Level III - 6 mg multiple oral dose of AEF0117 given on the morning of Day 1 to Day 7
The planned dose escalation schema may be amended based on the emerging PK and safety data, and an additional cohort may be added. Smaller dose escalation increments can also be implemented based on safety and PK results of previous dose levels. Each subject will participate in only one dose group.
Administration of AEF0117 to each dose cohort should not occur before participants in the previous dose cohort have been treated and data i.e. safety results and PK from those participants are reviewed in accordance with the protocol. Eligible subjects will be admitted to the research clinic at midday prior to dosing (Day -1) and remain in house until Day 14. Subsequently subjects will return to the research facility on an outpatient basis to have PK and safety assessments at 216 and 264 hours (Day 16 and Day 18) after the last dose (Day 7). PK samples and safety assessments will be done pre-dose and at different times post-dose.
Randomized subjects will receive a single oral dose per day on Days 1 through 7. Serial PK and PD blood samples and urine PK collections will be performed for 24 hours after the first dose administration (Day 1). Pre-dose PK and PD blood samples will then be obtained on Days 3, 4, 5 and 6 prior to the daily dose administration. Serial PK and PD blood samples and urine collections will be also performed for 48 hours after the last dose (Day 7), and blood samples will be obtained at 72, 96, 120, 144, 168, 216 and 264 hours after the last dose (Day 7).
Safety monitoring (physical examinations, vital sign measurement, 12 lead ECGs, clinical safety laboratory tests, and adverse event monitoring) will be performed throughout the study. Psychometrics tests (Bond \& Lader VAS, ARCI, POMS) will be performed on D1 and D7 at pre-dose, tmax and 24 hours post-dose. CSSRS test will be performed at pre-dose of D1 and at D8. tmax will be determine according to PK results obtained in the AEF0117-101 clinical study. Subjects will have a final follow up/Study termination safety evaluation on Day 18.
Three dose levels are planned for the study with 8 subjects (6 active and 2 placebo) per dose level:
Dose Level I - 0.6 mg multiple oral dose of AEF0117 given on the morning of Day 1 to Day 7 Dose Level II - 2 mg multiple oral dose of AEF0117 given on the morning of Day 1 to Day 7 Dose Level III - 6 mg multiple oral dose of AEF0117 given on the morning of Day 1 to Day 7
The planned dose escalation schema may be amended based on the emerging PK and safety data, and an additional cohort may be added. Smaller dose escalation increments can also be implemented based on safety and PK results of previous dose levels. Each subject will participate in only one dose group.
Administration of AEF0117 to each dose cohort should not occur before participants in the previous dose cohort have been treated and data i.e. safety results and PK from those participants are reviewed in accordance with the protocol. Eligible subjects will be admitted to the research clinic at midday prior to dosing (Day -1) and remain in house until Day 14. Subsequently subjects will return to the research facility on an outpatient basis to have PK and safety assessments at 216 and 264 hours (Day 16 and Day 18) after the last dose (Day 7). PK samples and safety assessments will be done pre-dose and at different times post-dose.
Randomized subjects will receive a single oral dose per day on Days 1 through 7. Serial PK and PD blood samples and urine PK collections will be performed for 24 hours after the first dose administration (Day 1). Pre-dose PK and PD blood samples will then be obtained on Days 3, 4, 5 and 6 prior to the daily dose administration. Serial PK and PD blood samples and urine collections will be also performed for 48 hours after the last dose (Day 7), and blood samples will be obtained at 72, 96, 120, 144, 168, 216 and 264 hours after the last dose (Day 7).
Safety monitoring (physical examinations, vital sign measurement, 12 lead ECGs, clinical safety laboratory tests, and adverse event monitoring) will be performed throughout the study. Psychometrics tests (Bond \& Lader VAS, ARCI, POMS) will be performed on D1 and D7 at pre-dose, tmax and 24 hours post-dose. CSSRS test will be performed at pre-dose of D1 and at D8. tmax will be determine according to PK results obtained in the AEF0117-101 clinical study. Subjects will have a final follow up/Study termination safety evaluation on Day 18.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01DA038875 | NIH | None | https://reporter.nih.gov/quic… | View |