Surrogate Biomarker of Oxidative Stress by Mass Spectroscopy
| Group | Value (micromole/M tyrosine) | Spread |
|---|---|---|
| Placebo Oral Tablet | -79.9 | 255.5 |
| GKT137831 | 13.3 | 39.3 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataShort name GKT137831
This trial does not test a peptide that PepBank tracks.
United States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
A placebo-controlled, multicenter, randomized trial to test GKT137831 in ambulatory patients with idiopathic pulmonary fibrosis. This drug is an inhibitor of nicotinamide adenine dinucleotide phosphate (NADPH) oxidase (NOX) isoforms. The investigators hypothesize the drug will decrease pulmonary injury due to reactive oxygen species (ROS) generated by NOX enzymes, which are believed to play an important role in the development of IPF. Treatment with GKT137831 could result in significant benefit for a lung disease that has, until now, been almost invariably inexorable. This clinical trial represents the bedside application of a series of NOX translational and basic studies and discoveries, over several years, from the laboratory of Dr. Victor Thannickal.
Experimental
GKT137831
GKT137831 will be administered orally, at a dose of 400 mg twice daily, for a total of 24 weeks.
Placebo comparator
Placebo Oral Tablet
Identically-appearing placebo oral tablets will be administered orally, twice daily, for a total of 24 weeks.
Outcomes the sponsor listed as primary.
Surrogate Biomarker of Oxidative Stress by Mass Spectroscopy
Time frame · From baseline thru week 24
Changes in concentrations of circulating o,o'-dityrosine, as determined by mass spectroscopy in plasma, in terms of absolute concentrations and percentages of baseline, will be compared within and between treatment arm participants.
Collagen Degradation Product by Enzyme Linked Immunoabsorbant Assay
Time frame · Baseline to week 24
Changes in concentrations of the collagen degradation product, serum C1M measured by enzyme linked immunsorbent assays will be compared between baseline values and those at 24 weeks, and between experimental arm and control participants.
Pulmonary Function by Spirometry
Time frame · Baseline to week 24
Forced vital capacity (FVC), measured by spirometer at baseline, will be compared to values at the conclusion of the study and between the two treatment arms.
Ambulatory Ability by Measuring Walk Distance in Six Minutes
Time frame · Baseline to week 24
Six-minute walk distance (6MWD) will be compared at baseline and as changes from baseline among experimental arm participants and control subjects
Evaluation of Safety by Adverse Events
Time frame · Up to week 24
The number of participants who had adverse events will be compared between experimental arm participants and those in the control arm.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (micromole/M tyrosine) | Spread |
|---|---|---|
| Placebo Oral Tablet | -79.9 | 255.5 |
| GKT137831 | 13.3 | 39.3 |
| Group | Value |
|---|---|
| GKT137831 | not posted |
| Placebo Oral Tablet | not posted |
| Group | Value (Liters) | Spread |
|---|---|---|
| GKT137831 | 2.8 | 0.9 |
| Placebo Oral Tablet | 2.7 | 0.8 |
| Group | Value (feet) | Spread |
|---|---|---|
| GKT137831 | 1190 | 440 |
| Placebo Oral Tablet | 1191 | 425 |
| Group | Value (participants) |
|---|---|
| GKT137831 | 19 |
| Placebo Oral Tablet | 17 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| GKT137831GKT137831 will be administered orally, at a dose of 400 mg twice daily, for a total of 24 weeks. GKT137831: GKT137831 is a NOX enzyme inhibitor | 0 / 30 | 7 / 30 | 19 / 30 |
| Placebo Oral TabletIdentically-appearing placebo oral tablets will be administered orally, twice daily, for a total of 24 weeks. Placebo Oral Tablet: see Arm/Group description | 0 / 28 | 3 / 28 | 17 / 28 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
No study cites this trial.
Who could join, as posted.
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