This trial is evaluating whether Bocidelpar will improve 6 primary outcomes and 5 secondary outcomes in patients with Reduced Maximum Oxygen Uptake Due to Poor Systemic Oxygen Extraction. Measurement will happen over the course of Baseline and Week 6.
This trial requires 40 total participants across 2 different treatment groups
This trial involves 2 different treatments. Bocidelpar is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.
"When systemic O₂ pulse-oxygen monitoring shows low or absent blood oxygen levels, the treatment is to administer 100% oxygen at a rate of 10 l/min. This should be repeated at least 60 min after delivery of this initial administration. This is recommended in cases of severe airway obstruction, which may have occurred from severe lung disease or mechanical ventilation of the respiratory system." - Anonymous Online Contributor
"The systemic oxygen extraction and uptake rates in normoxic individuals change in inverse proportion to the VO2max and may present as either an acute (i.e. transient) or chronic (i.e. non-transient) decrease in systemic oxygen uptake. The latter may occur during exercise. This is, in part, a consequence of central and peripheral compensations for altered cardiac contractility which is observed in the chronically hypoxia tolerant individuals." - Anonymous Online Contributor
"Recent findings indicate that maximal exercise in a patient with peripheral limitations of diffusion is not predictive of disease severity and could not be used as a single measure to assess the patient's clinical state." - Anonymous Online Contributor
"Reduced maximum oxygen uptake and an increased diffusion rate are signs of inadequate O2 delivery. Poor O2 delivery leads to increased tissue hypoxia, which in turn leads to increased erythropoietin production to compensate for oxygen delivery impairment. Although O2 delivery is still inadequate, O2 delivery recovery is occurring." - Anonymous Online Contributor
"We confirmed that reduced maximum oxygen uptake could not be cured, but we also demonstrated that a significant improvement could be obtained by switching from oxygen-enriched oxygen to oxygen-deprived oxygen with a high oxygen:carrier gas molarity of 1:1. Oxygen deprivation significantly increased the duration of survival after the onset of reduced maximum oxygen uptake." - Anonymous Online Contributor
"<18% of men age 60 years and over are thought to suffer from respiratory distress due to poor systemic oxygen extraction.<BR>
The incidence rates appear to be decreasing in recent years among these two populations. <BR>
The most probable reason for these trends is the effect of improved screening and diagnosis, but other reasons warrant further consideration." - Anonymous Online Contributor
"Bocidelpar can be effective for treating several forms of anemia, especially when given for three months or more. This is surprising because the drug increases baseline oxygen consumption. These data support the theory that, in addition to peripheral hemodynamics affecting pulmonary diffusion of oxygen, a low systemic PO (the difference in PO between arterial oxygen and venous oxygen) may play an important role in the pathogenesis of anemia in patients with sickle cell disease. Our preliminary data also suggest that anemia may be treated better using bocidelpar given in conjunction with other drugs." - Anonymous Online Contributor
"The majority of new agents for therapeutic use are based on the concept of synthetic non-protein compounds with structural diversity. In addition to the existing synthetic non-protein compounds, the development of new synthetic non-protein compounds with the capacity to modulate the mechanisms responsible for the development of the bocidelpar will likely result in new therapeutic agents based on synthetic non-protein compounds." - Anonymous Online Contributor
"It did not exacerbate the hypoxic response, even in the presence of high oxygen tension. The lack of synergy seems to be related to the different mechanisms of the two drugs." - Anonymous Online Contributor
"A single dose of oral bocidelpar is absorbed rapidly from the gastrointestinal tract. Peak plasma levels occur between 0.5 and 1.5 h after oral ingestion. After this, steady-state plasma concentrations of bocidelpar were reached within three days. Mean total, fasting, and post-methionine fasting concentrations were 0.4, 0.5, and 5.6 ng/mL in the high dose group, and 0.1, 0.3, and 2.1 ng/mL in the low dose group, respectively. The mean volume of distribution of this drug is 0.7 L/kg." - Anonymous Online Contributor
"Patients with decreased maximum oxygen uptake due to poor systemic oxygen extraction can often be accurately diagnosed with the use of routine clinical and blood testing in both the general population and in patients with suspected anaerobeemia. It is thought that routine testing of anaerobic bacteria and analysis of both glucose oxidation and lactate metabolism may, in addition to a baseline hemoglobin, be useful in identifying patients with reduced oxygen uptake of an anaerobic origin." - Anonymous Online Contributor
"The use of bocidelpar is feasible, safe and well-tolerated among patients with reduced baseline aerobic ability. Bocidelpar is associated with significantly improved quality of life, physical functioning, muscular strength, physical activity level and self-reported disability in patients with chronic heart failure." - Anonymous Online Contributor