Trials / Terminated
TerminatedNCT03069989
Single Doses of GSK3008348 in Idiopathic Pulmonary Fibrosis (IPF) Participants Using Positron Emission Tomography (PET) Imaging
A Study of Single Doses to Evaluate the Safety, Tolerability, Pharmacokinetics and Target Engagement of Nebulised GSK3008348 in Idiopathic Pulmonary Fibrosis Patients, Using Positron Emission Tomography (PET) Imaging
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
GSK3008348 is being developed as a treatment for IPF. A first-time-in-human study showed that single nebulized doses of 1-3000 micrograms (mcg) GSK3008348 in healthy volunteers were well tolerated, with pharmacokinetic (PK) exposures within the defined limits set in the protocol. The proposed study is a 2-cohort study of single doses, intended to evaluate the safety, tolerability and PK of the drug in participants with IPF not currently treated with pirfenidone or nintedanib, and to obtain preliminary information on target engagement. Cohort 1 will be a 2-period, randomized, double-blind, placebo-controlled group with at least 7 days washout between doses, and follow-up period of up to 7-14 days. Cohort 2 is optional. It will be designed to further explore safety and to provide additional information on the target engagement profile of GSK3008348. The total duration of the study will be up to 62 days.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GSK3008348 | Solution for nebulisation. Available as clear colorless to pale yellow colored solution in a 5mL vial with 20 millimeter (mm) stopper and aluminium seal yellow colored solution in a 5mL vial with 20 millimeter (mm) stopper and aluminium seal. |
| DRUG | Placebo | Solution for nebulisation. Available as clear colorless to pale yellow colored solution in a 5mL vial with 20mm stopper and aluminium seal. |
| DRUG | [18F]-FBA-A20FMDV2 | Radio-labeled peptide ligand for PET scan. Available as intravenous (IV) infusion, 20 mL. |
Timeline
- Start date
- 2017-06-13
- Primary completion
- 2018-07-04
- Completion
- 2018-07-18
- First posted
- 2017-03-03
- Last updated
- 2019-08-12
- Results posted
- 2019-08-12
Locations
3 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT03069989. Inclusion in this directory is not an endorsement.