Trials / Completed
CompletedNCT03457727
GSK1325756 Relative Bioavailability Study in Healthy Elderly Subjects
A Two Part, Randomized, Open-label, Cross Over Study in Healthy Elderly Participants to Evaluate the Relative Bioavailability of Hydrobromide Salt Tablet Formulations of Danirixin in the Fed and Fasted States, and to Evaluate the Effect of Food and Gastric Acid Secretion Suppression on Danirixin Pharmacokinetics Following Administration of Hydrobromide Salt Tablets
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 65 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
This 2-part study will be carried out on healthy elderly subjects to evaluate relative bioavailability of danirixin formulations. Part A will support the selection of the formulation and Part B will assess food effect, bioavailability and pharmacokinetic (PK) profile of selected formulation from Part A. Danirixin is currently administered with food, therefore the investigation of food effect for the selected formulation could potentially enable dosing without food. Approximately 16 subjects will be included in Part A and approximately 24 subjects will be included in Part B. Both parts will include a screening phase, treatment phase with in-between washout period and a follow-up phase.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Danirixin | Danirixin is being developed as a potential anti-inflammatory agent for the treatment of chronic obstructive pulmonary disorder (COPD) and other inflammatory diseases and influenza. Danirixin reference (600 mg) or test formulation (475 or 600 mg or 600 mg with 5 percent HPMC) immediate release tablets will be administered by oral route in a cross-over manner. |
| DRUG | Omeprazole | Omeprazole is used as an antacid. OMP 40 mg delayed-release capsule will be administered by oral route to randomized subjects. |
Timeline
- Start date
- 2018-03-07
- Primary completion
- 2018-07-25
- Completion
- 2018-07-25
- First posted
- 2018-03-07
- Last updated
- 2021-05-19
- Results posted
- 2019-08-28
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03457727. Inclusion in this directory is not an endorsement.