Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06278389
Status:
RECRUITING
Last Update Posted:
2024-03-05
First Post:
2024-01-23
Brief Title:
Single Ascending Dose Food Effects and Drug-Drug Interactions of ACC017 Tablets in Healthy Adult Participants
Sponsor:
Jiangsu Aidea Pharmaceutical Co Ltd
Organization:
Jiangsu Aidea Pharmaceutical Co Ltd
Study Overview
Official Title:
Study of Single Ascending Dose Food Effects and Drug-Drug Interactions of ACC017 Tablets in Healthy Adult Participants in China A Single-center Randomized Double-blind Placebo-controlled Two-Stage Trial
Status:
RECRUITING
Status Verified Date:
2024-01
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:
The objective of this clinical trial is to investigate the safety and tolerability of single ascending dose ACC017 tablets in Chinese healthy adult participants This study aims to address the following major questions
Recommended dosage for ACC017 tablets used in phase IbIIa trial
The pharmacokinetic PK characteristics of single dose ACC017 tablets
The effect of food FE on the PK of ACC017 tablets
Drug-drug interactions DDIs when ACC017 tablets are co-administered with emtricitabine and tenofovir alafenamide fumarate FTCTAF tablets II
Recommended dosage for ACC017 tablets used in phase IbIIa trial
The pharmacokinetic PK characteristics of single dose ACC017 tablets
The effect of food FE on the PK of ACC017 tablets
Drug-drug interactions DDIs when ACC017 tablets are co-administered with emtricitabine and tenofovir alafenamide fumarate FTCTAF tablets II
Detailed Description:
This is a single-center randomized double-blind placebo-controlled single ascending dose SAD two-stage phase Ia clinical trial in Chinese healthy adults to evaluate the safety tolerability PK FE and DDIs with FTCTAF of ACC017 tablets administered as a single dose in healthy participants
The trial will be divided into two stages the first stage is a single-center randomized double-blind placebo-controlled SAD study The study consists of six dose cohorts namely 5 mg 20 mg 40 mg 80 mg 120 mg and 160 mg cohorts whether to escalate to the 160 mg cohort will be determined or adjusted if applicable D2D7 and a subsequent discharge visit D8 Participants will receive a single oral dose of ACC017 tablets or placebo under fasting conditions
The second stage is a single-center randomized open-label FE and DDI study with a tentative dose of 40 mg The final administered dose will be determined after completion of the SAD study as assessed by the investigator and the sponsor Stage 2 is planned to enroll 12 healthy participants both males and females who are randomly assigned at a 11 ratio to either the fasting-postprandial group F-P group or the postprandial-fasting group P-F group with 6 participants in each group Eligible healthy participants are admitted on D-1 and receive a single oral dose of ACC017 tablets on the day of administration of each cycle under the fasting or postprandial condition with a washout period of 7 days during the two-week period After completing the second cycle of drug washout participants are evaluated by the investigator and enter into the DDI study and receive a single oral dose of ACC017 tablets with FTCTAF tablets under fasting condition
The study is divided into screening period no more than 28 days D-28 to D-1 FE first cycle D1 washout period A D2 to D7 FE second cycle D8 washout period B D9 to D14 DDI period D15 wahout period C D16 to D21 and discharge D22 visits
The trial will be divided into two stages the first stage is a single-center randomized double-blind placebo-controlled SAD study The study consists of six dose cohorts namely 5 mg 20 mg 40 mg 80 mg 120 mg and 160 mg cohorts whether to escalate to the 160 mg cohort will be determined or adjusted if applicable D2D7 and a subsequent discharge visit D8 Participants will receive a single oral dose of ACC017 tablets or placebo under fasting conditions
The second stage is a single-center randomized open-label FE and DDI study with a tentative dose of 40 mg The final administered dose will be determined after completion of the SAD study as assessed by the investigator and the sponsor Stage 2 is planned to enroll 12 healthy participants both males and females who are randomly assigned at a 11 ratio to either the fasting-postprandial group F-P group or the postprandial-fasting group P-F group with 6 participants in each group Eligible healthy participants are admitted on D-1 and receive a single oral dose of ACC017 tablets on the day of administration of each cycle under the fasting or postprandial condition with a washout period of 7 days during the two-week period After completing the second cycle of drug washout participants are evaluated by the investigator and enter into the DDI study and receive a single oral dose of ACC017 tablets with FTCTAF tablets under fasting condition
The study is divided into screening period no more than 28 days D-28 to D-1 FE first cycle D1 washout period A D2 to D7 FE second cycle D8 washout period B D9 to D14 DDI period D15 wahout period C D16 to D21 and discharge D22 visits
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CTR20240167 | REGISTRY | chinadrugtrialsorgcn | None |