Idiopathic Pulmonary Fibrosis
Conditions
Keywords
Fibrosis, Pulmonary Fibrosis, Lung Diseases, Interstitial
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.
Interventions
DRUGGS-6624
Patients will be treated with GS-6624 (125 or 200 mg) administered IV over 1 hour on specific days during the treatment period.
Sponsors
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Acceptable results on pulmonary function tests 2. At rest oxygen saturation ≥90% on room air 3. Adequate organ function
Exclusion criteria
1. High resolution computer tomography pattern showing emphysema that is greater than fibrosis 2. Acceptable results on whole body plethysmography 3. History of clinically significant hepatic or renal disease 4. Poorly controlled or severe diabetes mellitus 5. Use of systemic immunosuppressants within 28 days of GS-6624 infusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To characterize the safety, tolerability, and pharmacokinetics (PK) of GS-6624 | 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
| Measure | Time frame | Description |
|---|---|---|
| - 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 | Secondary Endpoints: * Anti-GS-6624 antibody formation; * Change in FVC and DLCO; * Change in SGRQ score. |
Countries
United States
Outcome results
None listed