Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2025-12-24 @ 2:59 PM
NCT ID:
NCT03450759
Brief Summary:
This study will evaluate pharmacokinetics (PK) of four different formulations with different release profiles of AZD9977 (PART A) in the fasted state, and one of the formulation will be selected for further development (Part B). In Part B, the influence of food on the PK of AZD9977 will be evaluated
Detailed Description:
This study is a randomized, open-label, single-center study conducted on 12 healthy male subjects. This consists of three periods:
* Screening period (only prior to Day-1)
* Residential/treatment period (Part A and Part B)
* Follow-up period (5 to 7 days after-final dose)
The study is divided into 2 parts: Part A and B. The subjects will participate in both Part A and Part B. Part A will be a 4-way cross-over study to compare the PK of 3 different solid formulations with different release rates with an oral suspension of AZD9977 in fasting conditions. Subjects in Part A will receive the following treatments on Days 1, 3, 5 and 7:
* AZD9977 oral suspension 15 mg/mL (15 mg/mL = 195 mg) (reference)
* AZD9977 capsule, 65 mg (3 x 65 mg = 195 mg)
* AZD9977 extended release (ER) capsule, 65 mg, fast (3 x 65 mg = 195 mg)
* AZD9977 ER capsule, 65 mg, intermediate release (Int) (3 x 65 mg = 195 mg) Subjects will be resident from 1 day before Part A until at least 36 hours post last dosing in Part A. Subjects will return to the unit for Part B after completion of Part A. There will be a washout period of at least 2 days between the doses for a subject. Based on the results in Part A, one of the solid formulations will be selected and evaluated in fed conditions on Day of Part B. Subjects will return to the unit for a final study visit 5 to 7 days post- dose in Part B. Each subject will be involved in the study for approximately 9 weeks.
Study:
NCT03450759
Study Brief:
Protocol Section:
NCT03450759