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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GS-6624 125mg | Experimental |
| |
| Experimental: GS-6624 200mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GS-6624 | Drug | Patients will be treated with GS-6624 (125 or 200 mg) administered IV over 1 hour on specific days during the treatment period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the safety, tolerability, and pharmacokinetics (PK) of GS-6624 | To characterize the safety, tolerability, and pharmacokinetics (PK) of GS-6624 after multiple intravenous (IV) administrations in subjects with idiopathic pulmonary fibrosis (IPF). | 113 days |
| Measure | Description | Time Frame |
|---|---|---|
| - 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 | Secondary Endpoints:
| 113 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zung Thai, MD | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Pulmonary Specialists | Scottsdale | Arizona | 85258 | United States | ||
| David Geffen School of Medicine at UCLA |
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|
| Los Angeles |
| California |
| 90095 |
| United States |
| Stanford University Medical Center | Stanford | California | 94305 | United States |
| Loess Hills Clinical Research Center | Council Bluffs | Iowa | 51503 | United States |
| UPMC Translational Research Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| D005355 | Fibrosis |
| D011658 | Pulmonary Fibrosis |
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000613471 | simtuzumab |
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