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The purpose of this study is to investigate the safety and tolerability of IX-01 after multiple doses, and to determine how the body handles IX-01.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| IX-01 | Experimental | Up to 4 different dose groups within 50 to 1,200 mg of IX-01 oral aqueous dispersion, administered once daily for 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Administered orally |
| |
| IX-01 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with One or More Drug Related Adverse Events (AEs) or any Serious AEs | Baseline to Day 20 (Estimated up to 3 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) of IX-01 | Pre-dose to 24 hours post dose on Days 1 and 10 | |
| Area Under the Plasma Concentration-Time Curve (AUCtau) | Pre-dose up to 24 hours post dose on Days 1 and 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Email: Ixchelsis@Choruspharma.com | Ixchelsis Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith Medicines Research (HMR) | London | United Kingdom |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 5, 2020 | |
| Reset | Aug 20, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 5, 2020 | Aug 20, 2020 |
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| Drug |
Administered orally |
|
| Time of Peak Plasma Concentration (Tmax) of IX-01 | Pre-dose to 24 hours post dose on Days 1 and 10 |
| Elimination Half Life (t1/2) of IX-01 | Pre-dose up to 96 hours post dose on Day 10 |
| Accumulation Ratio (Racc) of IX-01 based on AUCtau | Pre-dose up to 24 hours post dose on Day 10 |
| Accumulation Ratio (Racc) of IX-01 based on Cmax | Pre-dose up to 24 hours post dose on Days 1 and 10 |
| Area Under the Concentration-Time Curve (AUCt) from Zero to the Time of Last Quantifiable Concentration (AUC(0-t)) of IX-01 | Pre-dose to 96 hours post dose on Day 10 |
| Minimum Observed Concentration (Ctrough) of IX-01 | Pre-dose on Days 2 to 10 |
| Elimination Rate Constant (Kel) of IX-01 | Pre-dose up to 96 hours post dose on Day 10 |
| Apparent Clearance of IX-01 | Pre-dose up to 24 hours post dose on Day 10 |
| Apparent Volume of Distribution During the Terminal Phase of IX-01 | Pre-dose up to 96 hours post dose on Day 10 |
| Urine 6-β-hydroxycortisol/cortisol Ratio | Pre-dose on Day 1 and Day 10 |
| IX-01 Concentration and Amount Secreted in Semen | Between 2 and 4 hours after dosing, on Day 9 |