Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to investigate the safety and tolerability of 3 multiple and escalating dose regimens of CG400549 administered orally in healthy volunteers.
This is a Phase 1, 3 cohorts study consisting of a randomised, double-blind, and placebo-controlled design.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E1. CG400549 640mg | Experimental | CG400549 640mg BID on Day 1-5 and QD on Day 6 in the fed-state |
|
| E2: CG400549 320mg | Experimental | CG400549 320mg QD on Day 1-5 in the fed-state. |
|
| E3: CG400549 640mg | Experimental | CG400549 640mg QD on Day 1-5 in the fed-state. |
|
| E4: CG400549 960mg | Experimental | CG400549 960mg QD on Day 1-5 in the fed-state. |
|
| P1 Placebo | Placebo Comparator | Placebo 640mg BID on Day 1-5 and QD on Day 6 in the fed-state |
|
| P2: Placebo 320mg | Placebo Comparator | Placebo 320mg QD on Day 1-5 in the fed-state |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CG400549 640mg | Drug | multiple oral doses of 640 mg CG400549 (n=6) BID for 5 days (Days 1-5) and a final dose on Day 6 in the fed state |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | From Time the ICF is signed until Follow up Visit (15 days after study drug administration) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics-tmax(h), Cmax (ng/mL), Auc (0-24), T1/2(h) | To determine the pharmacokinetics of CG400549 following oral administration of multiple ascending doses of CG400549 in healthy male subjects. | Day1 and Day5 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Seonggu Ro, PhD | CrystalGenomics, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA International clinical center | Zuidlaren | Netherlands |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 16, 2022 | |
| Reset | Feb 22, 2023 | |
| Release | Feb 27, 2023 | |
| Reset | Dec 6, 2023 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 16, 2022 | Feb 22, 2023 | |||
| Feb 27, 2023 |
| ID | Term |
|---|---|
| C523750 | CG 400549 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| P3 Placebo 640mg | Placebo Comparator | Placebo 640mg QD on Day 1-5 in the fed-state. |
|
| P4: Placebo 960mg | Placebo Comparator | Placebo 960mg QD on Day 1-5 in the fed-state. |
|
| CG400549 320 mg | Drug | multiple oral doses of 320 mg CG400549 (n=6) QD for 5 days in the fed state |
|
| CG400549 640 mg | Drug | multiple oral doses of 640 mg CG400549 (n=6) QD for 5 days in the fed state |
|
| CG400549 960 mg | Drug | multiple oral doses of 960 mg CG400549 (n=6) QD for 5 days in the fed state |
|
| Placebo 640mg | Drug | multiple oral doses of 640 mg placebo (n=2) BID for 5 days (Days 1-5) and a final dose on Day 6 in the fed state |
|
| Placebo 320mg | Drug | multiple oral doses of 320 mg placebo (n=2) QD for 5 days in the fed state |
|
| placebo 960 mg | Drug | multiple oral doses of 960 mg placebo (n=2) QD for 5 days in the fed state |
|
| Placebo 640mg | Drug | multiple oral doses of 640 mg placebo (n=2) QD for 5 days in the fed state |
|
| Dec 6, 2023 |