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This is a Phase I Randomized,Double-Blind,Placebo-controlled Trial in Healthy Male Voluteers To Examine the Safety,Tolerability,and Pharmacokinetics of HMPL-011 After A Single Dose.
Eligible subjects will randomly recieve 1200 mg tablets (600 mg tablet X 2) or 1200 mg capsules (200 mg capsule X 6) of HMPL-011 under fed and fed circumstance in part 1. In part 2, eight subjects will be enrolled and given 800 mg tablets (400 mg/tablet X 2) every 8 hours daily for 6 days (morning dose only on Day 6).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HMPL-011 tablets | Active Comparator | A sigle total oral dose of 1200 mg tablets (600 mg tablet X 2) |
|
| HMPL-011 capsules | Active Comparator | A sigle total oral dose of 1200 mg capsules (200 mg tablet X 6) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HMPL-011 tablets | Drug | Eligible subjects will recieve 1200 mg HMPL-011 tablets under fed and diet circumstance. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) of HMPL-011 tablets vs capsules in fasted States | Peak Plasma Concentration (Cmax) of HMPL-011 tablets (600 mg tablet X 2) and capsules (200 mg capsule X 6) in fasted States. | 72 hours |
| Peak Plasma Concentration (Cmax) of HMPL-011 tablets vs capsules in fed States | Peak Plasma Concentration (Cmax) of HMPL-011 tablets (600 mg tablet X 2) and capsules (200 mg capsule X 6) in fed States. | 72 hours |
| Steady State concentration of HMPL-011 | Steady State concentration of HMPL-011 will be caculated based on Ctrough | 5 weeks |
| Area under the plasma concentration versus time curve (AUC) of HMPL-011 tablets vs capsules in fed States. | Area under the plasma concentration versus time curve (AUC) of HMPL-011 tablets (600 mg tablet X 2) and capsules (200 mg capsule X 6) in fed States. | 72 hours |
| Area under the plasma concentration versus time curve (AUC) of HMPL-011 tablets vs capsules in fasted States. | Area under the plasma concentration versus time curve (AUC) of HMPL-011 tablets (600 mg tablet X 2) and capsules (200 mg capsule X 6) in fasted States. | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Overall incidence of TEAEs | The proportion of subjects reported at least 1 TEAE | 5 weeks |
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Inclusion Criteria:
Subjects meeting the following criteria at the Screening Visit will be eligible to participate in the study:
Exclusion Criteria:
Subjects are excluded from participation in the study if any of the following criteria apply:
The following items are not to be consumed for 48 hours (2 days) prior to the first dose until the last scheduled blood sample collection of the study:
The following items are not to be consumed for 14 days prior to the first dose and throughout the study until the last scheduled blood sample collection:
• Grapefruit, pomelo, cranberry, or grapefruit, pomelo, or cranberry-containing products. While in the CPU, subjects will not be allowed additional sugar in beverages or on cereal, though limited use of other sweeteners is allowed.
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| HMPL-011 capsules | Drug | Eligible subjects will recieve 1200 mg HMPL-011 capsules under fed and diet circumstance. |
|