Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-01-02 @ 4:18 AM
Study NCT ID:
NCT05932459
Status:
COMPLETED
Last Update Posted:
2024-11-20
First Post:
2023-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Bioavailability, Food Effect and Pharmacokinetics of Deuremidevir Hydrobromide for Suspension
Sponsor:
Vigonvita Life Sciences
Organization:
Study Overview
Official Title:
A Phase I Clinical Study to Evaluate the Bioavailability, Food Effect and Pharmacokinetic Characteristics of Oral Deuremidevir Hydrobromide for Suspension in Chinese Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2023-06
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:
This study is divided into three parts: bioavailability study (hereinafter referred to as "BA study"), food effect study (hereinafter referred to as "FE study") and pharmacokinetic characteristics study (hereinafter referred to as "PK characteristics study"). A total of 38 subjects are planned to be enrolled. The three parts of the study can be carried out simultaneously, and there is no order requirement. The subjects will be assigned to one of them according to the enrollment order. Dose selection is 100mg, 300mg and 25mg.
Detailed Description:
BA study plan included 18 subjects, in the form of dry suspension and tablets, with a dose of 100 mg. Subjects were randomly divided into two sequences, TR and RT, with 9 cases in each sequence. They were given once in fasted condition each period, and the dry suspension and tablets were designed in a double crossover way.
12 subjects were enrolled in the FE study plan, and the dose was 300mg in dry suspension. Subjects were randomly divided into two sequences, sequence 1 and sequence 2, with 6 cases in each sequence, and given once per period. Fasting and infant formula milk double crossover were tested in two periods according to the administration sequence.
PK study form is dry suspension, the doses are 25 mg, 100 mg, 300 mg, taken orally once in fasted condition. 8 subjects will be enrolled in the 25mg group. The 100 mg group used the data of 18 subjects with dry suspension in BA study, while the 300 mg group used the fasting condition data of 12 subjects with dry suspension in FE study. The 100 mg and 300 mg groups will not be enrolled separately.
12 subjects were enrolled in the FE study plan, and the dose was 300mg in dry suspension. Subjects were randomly divided into two sequences, sequence 1 and sequence 2, with 6 cases in each sequence, and given once per period. Fasting and infant formula milk double crossover were tested in two periods according to the administration sequence.
PK study form is dry suspension, the doses are 25 mg, 100 mg, 300 mg, taken orally once in fasted condition. 8 subjects will be enrolled in the 25mg group. The 100 mg group used the data of 18 subjects with dry suspension in BA study, while the 300 mg group used the fasting condition data of 12 subjects with dry suspension in FE study. The 100 mg and 300 mg groups will not be enrolled separately.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: