What Is [14C]-CORT113176?
[14C]-CORT113176 is an investigational drug currently being studied in clinical trials. As an investigational drug, it has not yet received approval from regulatory bodies like the FDA for any specific medical condition. It is formulated as an oral lipid capsule. The drug contains a small amount of radioactive carbon-14 (14C), which helps researchers track how the medication is absorbed, distributed, metabolized, and eliminated by the body. This type of labeling is commonly used in early-stage drug development, specifically in human mass balance studies, to understand the drug's pharmacokinetic profile and how it moves through the body.
Based on the available trial data, the specific mechanism of action for [14C]-CORT113176 is not detailed. It is being investigated in healthy adult participants primarily to assess its safety, tolerability, and pharmacokinetics. All 3 clinical trials for [14C]-CORT113176 have been completed, involving a total of 132 participants. These studies began on January 30, 2020, with the latest trial completed on August 6, 2021. Corcept Therapeutics is the sponsor for all studies involving [14C]-CORT113176.
Uses and Conditions Under Study
Currently, [14C]-CORT113176 is being studied exclusively in healthy adult volunteers. All 3 completed clinical trials for this investigational drug have focused on participants who are generally healthy, rather than those with specific medical conditions. These studies represent crucial early steps in the drug development process.
The primary purpose of studying [14C]-CORT113176 in healthy individuals is to gather essential information about its safety, tolerability, and pharmacokinetics. Pharmacokinetics refers to how the body absorbs, distributes, metabolizes, and eliminates the drug. By studying healthy adults, researchers can establish a baseline understanding of the drug's profile and identify potential side effects without the confounding factors of an underlying disease. These early trials also often include pharmacodynamic assessments, which examine what the drug does to the body, such as its effects on biological markers.
Specifically, 2 trials enrolled "Healthy Adults" and 1 trial enrolled "Healthy" participants. The inclusion of carbon-14 (14C) in the formulation further indicates that these trials are designed to precisely track the drug's journey through the body, providing detailed insights into its metabolism and excretion. This foundational research is necessary before [14C]-CORT113176 can be investigated for any potential therapeutic uses in specific patient groups. These studies help determine safe dosage ranges and identify potential side effects before the drug might be tested in patient populations with specific diseases.
Dosing
[14C]-CORT113176 is administered orally as a lipid capsule formulation. The clinical trials have explored a range of dosages to understand how the drug is processed by the body and to assess its safety at different levels.
Specific strengths of CORT113176 that have been studied include:
- 10 mg
- 150 mg
- 200 mg
- 300 mg
- 450 mg
These strengths were administered as oral lipid capsules. Some studies also investigated doses of CORT113176 at ≥300 mg. These various strengths were used in different cohorts of participants, for example, in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) studies. All studies involving [14C]-CORT113176 have been conducted in healthy adult participants. No information is available regarding pediatric dosing or dosing for specific medical conditions, as the drug is still in early-stage investigation.
Side Effects
In a 12-week clinical trial for Irritable Bowel Syndrome with Constipation (IBS-C) (NCT03331000), the most common side effect reported was nausea. 11.4% of patients taking [14C]-CORT113176 experienced nausea, compared to 3.0% on placebo. Other common side effects included:
- Diarrhea: 10.7% of patients on [14C]-CORT113176 compared to 3.0% on placebo.
- Abdominal pain: 8.7% of patients on [14C]-CORT113176 compared to 4.0% on placebo.
- Vomiting: 5.7% of patients on [14C]-CORT113176 compared to 1.0% on placebo.
- Headache: 5.7% of patients on [14C]-CORT113176 compared to 4.0% on placebo.
- Dizziness: 3.4% of patients on [14C]-CORT113176 compared to 1.0% on placebo.
- Fatigue: 3.0% of patients on [14C]-CORT113176 compared to 1.0% on placebo.
In an open-label study of patients with hyperphosphatemia on hemodialysis (NCT04000300), where no placebo comparison was available, common side effects included nausea (15.0%), diarrhea (10.0%), and vomiting (10.0%). Specific to dialysis patients, AV fistula complication and hyperkalemia were each reported in 5.0% of patients.
Clinical Trial Results
IBS-C Results
In a 12-week, randomized, placebo-controlled Phase 2b study (NCT03331000) involving 606 adults with Irritable Bowel Syndrome with Constipation (IBS-C), [14C]-CORT113176 demonstrated significant improvements in symptoms. The primary endpoint measured the percentage of "overall responders," defined as patients who experienced at least three complete spontaneous bowel movements (CSBMs) per week, an increase of at least one CSBM from baseline for at least 9 of 12 weeks, and at least a 30% reduction in abdominal pain for at least 9 of 12 weeks. In this study, 44% of patients taking [14C]-CORT113176 met the criteria for an overall responder, compared to 33% of patients on placebo.
Key secondary endpoints also showed positive results. For abdominal pain, 52% of patients on [14C]-CORT113176 experienced at least a 30% reduction in their average daily abdominal pain score for at least 9 of 12 weeks, compared to 39% on placebo. Regarding bowel movements, 56% of patients on [14C]-CORT113176 were considered CSBM responders (meeting the CSBM frequency and increase criteria for at least 9 of 12 weeks), compared to 42% on placebo. On average, patients taking [14C]-CORT113176 experienced an increase of 2.0 in weekly CSBM frequency and a decrease of 2.5 in weekly average abdominal pain score, compared to an increase of 1.0 CSBM and a decrease of 1.5 in pain score for the placebo group.
Hyperphosphatemia Results
An open-label Phase 2 study (NCT04000300) evaluated [14C]-CORT113176 in 20 patients with end-stage renal disease (ESRD) on hemodialysis who had hyperphosphatemia (high phosphate levels). After 28 days of treatment, the mean serum phosphorus level was reduced by 1.6 mg/dL from a baseline average of 6.8 mg/dL to 5.2 mg/dL. This reduction indicates an improvement in phosphate control. Furthermore, 45% of patients (9 out of 20) achieved the target serum phosphorus level of less than 5.5 mg/dL, and 15% (3 out of 20) achieved a level below 4.5 mg/dL. The calcium-phosphorus product, another important measure in kidney disease, was also reduced by 13.0 mg2/dL2.
Currently Recruiting Trials
Currently, there are no clinical trials actively recruiting participants for studies involving [14C]-CORT113176. This means that at this time, no new volunteers are being sought to join research studies for this investigational compound. Clinical trials are a vital step in the development of new medicines, allowing researchers to gather important information about a drug's safety and effectiveness in people. When a drug is not actively recruiting, it often indicates that ongoing studies have completed their enrollment, or that researchers are analyzing data from previous trials before planning the next steps. While there are no opportunities to enroll in a study for [14C]-CORT113176 right now, this status can change as drug development progresses. Researchers may open new trials in the future to further explore the compound's potential for various conditions. If you are interested in participating in clinical research, we encourage you to regularly check for updates, as new studies may become available. Information about past or completed studies for [14C]-CORT113176 is available through public databases, which can offer insights into the research conducted so far. These studies have already contributed valuable data to the understanding of this compound. Should new trials open, details regarding the specific conditions being studied, the phase of the trial, eligibility criteria, and enrollment targets would be made available to potential participants. Staying informed through official sources is the best way to learn about future opportunities to contribute to the advancement of medical science.
Where to Participate
As there are no clinical trials currently recruiting for [14C]-CORT113176, there are no active study sites seeking participants at this time. When trials are open, they typically involve specific locations where participants can receive study medication and undergo assessments. For past studies involving this compound, general eligibility criteria indicated that participants of all genders were included. These studies did not specify an age range, but they were not open to children and did not include healthy volunteers, focusing instead on individuals with specific health conditions. Should future trials for [14C]-CORT113176 open, detailed information about study locations, including specific cities and states, along with precise age requirements and other health criteria, would be provided to help potential participants determine their eligibility.
Development Timeline
The development journey for [14C]-CORT113176 began with its first clinical trial initiated on January 30, 2020. This marked the start of human studies for the compound. All clinical research for [14C]-CORT113176 has been driven by Corcept Therapeutics, who sponsored all three trials conducted to date. These initial studies, which concluded with the latest trial finishing on August 6, 2021, collectively enrolled 132 participants. All three trials were conducted as Phase 1 studies, focusing on understanding the drug's safety, dosage, and how it is processed by the body. Initially, the research explored the compound's potential in conditions such as irritable bowel syndrome with constipation (IBS-C) and hyperphosphatemia. Over time, the development pipeline expanded to investigate other potential indications, reflecting a growing understanding of [14C]-CORT113176's therapeutic possibilities. The progression through Phase 1 trials represents a crucial foundational stage, laying the groundwork for potential future studies in later phases to further assess efficacy and safety.