A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-6624 in Adult Subjects With Idiopathic Pulmonary Fibrosis
Overview
- Phase
- Phase 1
- Intervention
- GS-6624
- Conditions
- Idiopathic Pulmonary Fibrosis
- Sponsor
- Gilead Sciences
- Enrollment
- 48
- Locations
- 7
- Primary Endpoint
- To characterize the safety, tolerability, and pharmacokinetics (PK) of GS-6624
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The study consists of 2 parts: Part A is a randomized, multiple-dose, double-blind, placebo-controlled sequential dose escalation study to evaluate GS-6624 in subjects with Idiopathic Pulmonary Fibrosis (IPF) and was completed in October 2011.
Part B is a randomized, two-dose, open-label dose expansion study to evaluate GS-6624 in subjects with IPF and is currently enrolling.
Detailed Description
The primary objective of this study is to characterize the safety, tolerability, and PK of GS-6624 after multiple IV administrations in patients with IPF. The secondary objectives are to evaluate the formation of anti-GS-6624 antibodies and to measure the effects of GS-6624 on FVC, DLCO, and SGRQ score. A total of 48 patients will be enrolled. In the double-blind phase (Part A), a total of 18 patients were enrolled at 3 dose levels. Part A was completed in October 2011. In Part B, 30 patients will be enrolled at 2 dose levels. Part B is open-label and is currently enrolling.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Acceptable results on pulmonary function tests
- •At rest oxygen saturation ≥90% on room air
- •Adequate organ function
Exclusion Criteria
- •High resolution computer tomography pattern showing emphysema that is greater than fibrosis
- •Acceptable results on whole body plethysmography
- •History of clinically significant hepatic or renal disease
- •Poorly controlled or severe diabetes mellitus
- •Use of systemic immunosuppressants within 28 days of GS-6624 infusion
Arms & Interventions
GS-6624 125mg
Intervention: GS-6624
Experimental: GS-6624 200mg
Intervention: GS-6624
Outcomes
Primary Outcomes
To characterize the safety, tolerability, and pharmacokinetics (PK) of GS-6624
Time Frame: 113 days
To characterize the safety, tolerability, and pharmacokinetics (PK) of GS-6624 after multiple intravenous (IV) administrations in subjects with idiopathic pulmonary fibrosis (IPF).
Secondary Outcomes
- - To evaluate the formation of anti-GS-6624 antibodies. - To assess the effects of GS-6624 treatment on force vital capacity (FVC) and carbon dioxide diffusing capacity (DLCO) - To assess the effects of GS-6624 treatment on SGRQ(113 Days)