Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2025-12-25 @ 8:05 PM
Study NCT ID:
NCT03002935
Status:
COMPLETED
Last Update Posted:
2017-04-05
First Post:
2016-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Safety Study of Orally Administered BPM31510 in Healthy Subjects
Sponsor:
BPGbio
Organization:
Study Overview
Official Title:
A Phase I Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Orally Administered BPM31510 in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2017-01
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:
This is an open-label, Phase I study of the bioavailability and safety of BPM31510 administered orally in healthy subjects dosed 3 times daily for 14 days. The last study dose is administered on Day 15 (one morning dose only). The study will consist of 25 subjects.
Detailed Description:
Study subjects will be admitted to the clinic on Day -1. All subjects will self-administer the Day 1 doses of study drug under supervision of the clinic staff. Doses of 3200 mg will be administered three times per day before meals.
Dosing will continue for an additional 14 days on an outpatient basis with Day 5 morning dose and the last study dose on Day 15 to be administered at the clinic (one morning dose, is given on Day 15).
On Days 1, 2, 5 and 15, pharmacokinetic (PK) and pharmacodynamics (PD) sampling will be performed 30 minutes prior to the first dose, and 0.5, 1, 2, and 4 hours after the first dose at all visits with an additional PK draw on Day 1 at 0.5, 1, 2, and 4 after the second dose. Urine for PK/PD will be collected pre-dose on Day 1, Day 2, Day 5 and Day 15. At all visits (on Days 1, 2, 5 and at the final dose on Day 15), samples will be collected for chemistry, Complete Blood Count (CBC), International normalized ratio (INR), prothrombin time (PT), partial thromboplastin time (PTT), cholesterol, low density lipoprotein (LDL), and high density lipoprotein (HDL), and vitamin K level. Blood samples for PK/PD will be collected 30 minutes prior to the morning dose on Day 5 and Day 15 and also at 0.5, 1, 2, and 4 hours after dosing. Lab samples (chemistry, etc.), will also be drawn at the time of the first PK/PD draw on Day 5 and Day 15.
A phone interview will be conducted no fewer than 25 days and no more than 35 days after the last dose on Day 15 to collect information on concomitant medications and adverse events Graded using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Dosing will continue for an additional 14 days on an outpatient basis with Day 5 morning dose and the last study dose on Day 15 to be administered at the clinic (one morning dose, is given on Day 15).
On Days 1, 2, 5 and 15, pharmacokinetic (PK) and pharmacodynamics (PD) sampling will be performed 30 minutes prior to the first dose, and 0.5, 1, 2, and 4 hours after the first dose at all visits with an additional PK draw on Day 1 at 0.5, 1, 2, and 4 after the second dose. Urine for PK/PD will be collected pre-dose on Day 1, Day 2, Day 5 and Day 15. At all visits (on Days 1, 2, 5 and at the final dose on Day 15), samples will be collected for chemistry, Complete Blood Count (CBC), International normalized ratio (INR), prothrombin time (PT), partial thromboplastin time (PTT), cholesterol, low density lipoprotein (LDL), and high density lipoprotein (HDL), and vitamin K level. Blood samples for PK/PD will be collected 30 minutes prior to the morning dose on Day 5 and Day 15 and also at 0.5, 1, 2, and 4 hours after dosing. Lab samples (chemistry, etc.), will also be drawn at the time of the first PK/PD draw on Day 5 and Day 15.
A phone interview will be conducted no fewer than 25 days and no more than 35 days after the last dose on Day 15 to collect information on concomitant medications and adverse events Graded using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: