Trials / Completed
CompletedNCT04032821
To Evaluate the Effect of Food on the Pharmacokinetic Characteristics of Alkotinib Capsules in Healthy Subjects
To Evaluate the Effect of Food on the Pharmacokinetic Characteristics of Alkotinib Capsules in Healthy Subjects,A Single Center, Open, Randomized, Single Dose, Two Period, Two Sequence, Crossover Phase I Clinical Trial
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
To evaluate the safety and tolerability of food to Alkotinib Capsules in healthy subjects
Detailed description
Alkotinib is an insulin receptor tyrosine kinase inhibitor that selectively inhibits anaplastic lymphoma Kinase and proto-oncogene protein ROS1。Alkotinib is expected to be used in the treatment of ALK positive and ROS1 positive metastatic non-small cell lung Cancer and other cancers include patients with non-small cell lung cancer who are resistant to treatment with the first generation ALK inhibitor, such as kezotinib。
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Alkotinib（300mg) | 1\. First empty stomach, after the meal.2. After eating first, after fasting. |
Timeline
- Start date
- 2019-11-20
- Primary completion
- 2019-12-16
- Completion
- 2019-12-16
- First posted
- 2019-07-25
- Last updated
- 2021-04-12
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04032821. Inclusion in this directory is not an endorsement.