Tradipitant for Nausea and Vomiting

Recruiting at 1 trial location

Overseen By Vanda Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Vanda Pharmaceuticals

Disqualifiers: Gastrointestinal disorders, NK-1 intolerance, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have been on any investigational medication in the past 60 days, you may not be eligible to participate.

What data supports the effectiveness of the drug Tradipitant for nausea and vomiting?

Tradipitant, a drug that blocks certain receptors involved in nausea, was shown to significantly reduce vomiting and motion sickness symptoms in a study with participants on boat trips. This suggests it could be effective for nausea and vomiting in other situations as well. ^{1 2 3 4 5}

How does the drug Tradipitant differ from other treatments for nausea and vomiting?

Tradipitant is unique because it is a neurokinin-1 (NK1) receptor antagonist, which targets specific pathways in the brain and gut involved in nausea and vomiting. This mechanism is different from other treatments, making it potentially effective for conditions like motion sickness and gastroparesis, where traditional therapies may not provide adequate relief. ^{1 2 3 6 7}

What is the purpose of this trial?

The goal of this study is to measure the effects of using Tradipitant after GLP-1R agonist use on nausea and vomiting in healthy overweight, class I, or class II obese volunteers. The study is placebo-controlled with two treatment arms.

Research Team

Vanda Pharmaceuticals

Principal Investigator

Vanda Pharmaceuticals

Eligibility Criteria

This trial is for healthy overweight individuals or those with class I or II obesity who experience nausea and vomiting after using GLP-1R agonist medications. Specific eligibility details are not provided, but typically participants must meet certain health criteria to join.

Inclusion Criteria

I do not have serious health issues or diabetes.

Body Mass Index 25-40 kg/m^2 inclusive

Exclusion Criteria

History of intolerance and/or hypersensitivity to NK-1 receptor antagonists

I have a condition that affects my stomach or intestines.

History of intolerance and/or hypersensitivity to GLP-1 receptor agonists

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either tradipitant or placebo BID for approximately 2 weeks

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• Tradipitant

Trial Overview The study is testing the effectiveness of Tradipitant in reducing nausea and vomiting compared to a placebo in volunteers who have taken GLP-1R agonists. It's a controlled trial with two groups: one receiving Tradipitant and the other receiving a placebo.

Participant Groups

Group I: Tradipitant Group Experimental Treatment 1 Intervention

Treatment with tradipitant BID for approximately 2 weeks

Group II: Placebo Group Placebo Group 1 Intervention

Treatment with placebo BID for approximately 2 weeks

Who Is Running the Clinical Trial?

Vanda Pharmaceuticals

Lead Sponsor

Trials

68

Recruited

19,900+

Findings from Research

In a study involving 126 adults, the NK1 receptor antagonist tradipitant significantly reduced the incidence of vomiting in participants experiencing motion sickness compared to a placebo, especially in rough sea conditions (tradipitant 15.79% vs. placebo 72.22%).

Tradipitant also led to lower overall motion sickness symptoms, with a mean severity score of 3.19 compared to 4.57 for the placebo group, indicating its potential as an effective treatment for nausea and vomiting associated with motion sickness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tradipitant in the Treatment of Motion Sickness: A Randomized, Double-Blind, Placebo-Controlled Study. Polymeropoulos, VM., Czeisler, MÉ., Gibson, MM., et al.[2023]

In a study involving 24 healthy volunteers, tradipitant (85 mg twice daily for 9 days) did not significantly affect gastric motor functions such as gastric emptying (GE) or gastric volumes (GV) compared to placebo.

The lack of impact on gastric emptying is crucial for considering tradipitant as a treatment option for patients with gastroparesis, as it suggests that the drug does not worsen this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical trial: a single-centre, randomised, controlled trial of tradipitant on satiation, gastric functions, and serum drug levels in healthy volunteers. Khanna, L., Zheng, T., Atieh, J., et al.[2022]

In phase 3 trials involving patients receiving highly or moderately emetogenic chemotherapy, the addition of rolapitant to standard antiemetic therapy significantly improved quality of life, as measured by the Functional Living Index-Emesis (FLIE).

Rolapitant not only enhanced overall FLIE scores but also specifically reduced nausea and vomiting scores, with a higher percentage of patients reporting no impact on daily life compared to those receiving placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rolapitant improves quality of life of patients receiving highly or moderately emetogenic chemotherapy. Chasen, M., Urban, L., Schnadig, I., et al.[2019]

Aprepitant is safe and well tolerated in both healthy Chinese and Caucasian subjects, with no serious adverse events reported during the study.

The pharmacokinetics (PK) of aprepitant, including key measures like maximum plasma concentration and area under the concentration-time curve, were comparable between the two ethnic groups after a single dose, indicating similar drug behavior across populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Pharmacokinetics of Aprepitant in Healthy Chinese and Caucasian Subjects. Yang, MJ., Xu, HR., Li, H., et al.[2022]

In a study of 401 patients receiving carboplatin-based chemotherapy, rolapitant significantly improved the complete response rate for preventing chemotherapy-induced nausea and vomiting (CINV), achieving 80.2% compared to 64.6% in the placebo group.

Rolapitant also demonstrated superior efficacy in preventing nausea and emesis during both the overall and delayed phases after chemotherapy, with a similar safety profile to the placebo, indicating it is a safe and effective addition to antiemetic regimens for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the neurokinin-1 receptor antagonist rolapitant in preventing nausea and vomiting in patients receiving carboplatin-based chemotherapy. Hesketh, PJ., Schnadig, ID., Schwartzberg, LS., et al.[2022]

In a double-blind trial involving 152 adults with gastroparesis, the NK1 receptor antagonist tradipitant significantly reduced nausea severity and increased nausea-free days compared to placebo, demonstrating its efficacy in managing symptoms of this condition.

Patients with baseline nausea and vomiting experienced even greater improvements with tradipitant, highlighting its potential as a targeted treatment for those most affected by gastroparesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Tradipitant in Patients With Diabetic and Idiopathic Gastroparesis in a Randomized, Placebo-Controlled Trial. Carlin, JL., Lieberman, VR., Dahal, A., et al.[2021]

Aprepitant, the first neurokinin-1-receptor antagonist, significantly enhances protection against nausea and vomiting caused by cisplatin-based and moderately emetogenic chemotherapy, improving delayed emesis by about 20%.

Combining aprepitant with standard antiemetic treatments (5-HT(3) receptor antagonist and dexamethasone) provides better overall emesis control, suggesting this combination should be adopted as a new standard therapy for patients undergoing chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurokinin-1-receptor antagonists: a new approach in antiemetic therapy. Jordan, K.[2018]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Tradipitant in the Treatment of Motion Sickness: A Randomized, Double-Blind, Placebo-Controlled Study. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Clinical trial: a single-centre, randomised, controlled trial of tradipitant on satiation, gastric functions, and serum drug levels in healthy volunteers. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Rolapitant improves quality of life of patients receiving highly or moderately emetogenic chemotherapy. [2019]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Comparison of Pharmacokinetics of Aprepitant in Healthy Chinese and Caucasian Subjects. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Efficacy of the neurokinin-1 receptor antagonist rolapitant in preventing nausea and vomiting in patients receiving carboplatin-based chemotherapy. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Tradipitant in Patients With Diabetic and Idiopathic Gastroparesis in a Randomized, Placebo-Controlled Trial. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Neurokinin-1-receptor antagonists: a new approach in antiemetic therapy. [2018]