Querã¨taro, Mexico

A Phase 1b Study of the NLRP3 Inhibitor VENT-02 in Patients With Mild to Moderate Parkinson's Disease

A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ALD-102 Solution in Subjects With Alopecia Areata

To Evaluate the Efficacy of CVN424 in Parkinson's Disease Participants With Motor Complications

Efficacy and Safety of VDPHL01 in Males With AGA

Effects of a Hemp Product on the Pharmacokinetics and Pharmacodynamics of Clopidogrel

The popularity of cannabis products has grown exponentially over the past decade as several states continue to decriminalize or legalize recreational and/or medicinal use. Cannabis contains >500 phytoconstituents, including >100 cannabinoids. The most well-studied cannabinoids are tetrahydrocannabinol (THC) and cannabidiol (CBD). Although both are psychoactive, THC produces the characteristic "high," while CBD does not. CBD is available as a prescription drug (Epidiolex®) to treat seizure disorders. Hemp, a popular CBD-containing botanical product, is defined as containing <0.3% THC. Hemp was federally legalized in the United States in 2018 following passage of the Farm Bill. Since passage of that bill, hemp and other CBD-containing products have become widely available over the counter. As such, hemp/CBD products have become top-selling botanicals, with sales projected to reach nearly $4.5 billion by 2024. Common uses include self-treatment for pain, anxiety, and sleep disorders. Despite increasing use of cannabis products, the pharmacokinetic interaction potential with pharmaceutical medications remains understudied. Previous pharmacokinetic studies have yielded convincing evidence that CBD significantly inhibits the activity of the drug metabolizing enzyme cytochrome P450 (CYP) 2C19. Despite the valuable information generated by these and numerous other studies, several unanswered questions about CBD-containing products remain: 1. Do real-world doses and dosing regimens of CBD (< 300 mg) have similar CYP interaction potential as that of higher doses investigated in previous pharmacokinetic studies? 2. What are the effects of CBD on high-impact CYP2C19 substrates, such as the anti-platelet drug clopidogrel (Plavix®)? 3. Does chronic administration of a real-world dose of CBD have similar interaction potential as a very high single dose of CBD? The primary objective of the proposed study is to evaluate the effects of a well-characterized, widely used hemp product on the pharmacokinetics of the commonly prescribed CYP2C19 substrate clopidogrel (Plavix®) in healthy adult participants who are confirmed to be CYP2C19 normal, rapid, or ultra-rapid metabolizers. Results could be used to inform a future study design involving elderly people, which is a population of interest. Results could also be used to guide healthcare providers in helping their patients make informed decisions about the safe use of hemp

Evaluating the Pharmacokinetics of Oregano and Potential Oregano-drug Interactions Using a Drug Cocktail Approach

Oregano (Origanum vulgare) is a flowering plant native to Europe. The fresh or dried leaves are commonly used as a cooking herb. Oregano oil extracts are also marketed as herbal supplements. O. vulgare ranked as the number 12 top-selling herbal supplement in the natural channel in 2022. Oregano supplements are consumed for myriad purported medicinal properties, including antimicrobial, antioxidant, and anti-inflammatory effects. Oregano contains multiple types of compounds, including phenols, terpenes, and terpenoids. Recent compelling in vitro data showed that an extract of O. vulgare activated the human pregnane X receptor (PXR) and aryl hydrocarbon receptor (AhR), which regulate the expression and activity of the prominent drug metabolizing enzymes cytochrome P450 (CYP) 3A4 and CYP1A2, respectively. PXR also regulates the expression and activity of several other CYPs (e.g., CYP2C9, CYP2C19), as well as transporters (e.g., the efflux transporter P-glycoprotein (P-gp)). The extent of activation of both receptors by O. vulgare rivaled that of St. John's wort, a well-known herbal supplement that induces CYP and P-gp activity in human participants. These investigators next evaluated the effects of O. vulgare on CYP3A4 and CYP1A2 activity in human hepatocytes. Again, the extent of induction by O. vulgare rivaled that of St. John's wort. Collectively, these observations suggest that oregano supplements could precipitate numerous interactions with pharmaceutical drugs. The primary objective of the proposed study is to evaluate the potential for a well-characterized O. vulgare product to precipitate pharmacokinetic interactions with a "cocktail" of oral drugs that are substrates for multiple CYPs. The investigators and others have shown this validated cocktail (caffeine, dextromethorphan, losartan, midazolam, and omeprazole) to be safe to administer to healthy adult participants. The secondary objective is to determine the pharmacokinetics of the oregano supplement, which to date have not been rigorously characterized in humans. Results will be used to help inform healthcare practitioners and consumers about the safe use of this increasingly popular herbal supplement when consumed with certain pharmaceutical drugs.

A Trial of Lu AF82422 in Participants With Multiple System Atrophy (MSA)

This study will consist of a 3-6-week screening period, a 72-week placebo-controlled period (PCP), and will include a 72-week optional dose-blinded open-label treatment extension (OLE) period. Participants in the PCP will be randomized to Lu AF82422 high dose, Lu AF82422 low dose or placebo (1:1:1). All participants entering the OLE will receive Lu AF82422 during the OLE. Participants will receive intravenous infusions approximately every 4 weeks during both the PCP and OLE.

Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1

A Phase 3 Study to Evaluate Petosemtamab Compared With Investigator's Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma Patients

This is a phase 3 open-label, randomized, controlled, multicenter study to compare petosemtamab vs investigator's choice monotherapy in HNSCC patients for the second- and third-line treatment of incurable metastatic/recurrent disease. HNSCC patients must have progressive disease (PD) on or after anti-PD-1 therapy and platinum-containing therapy. Patients treated with platinum-containing therapy only in the adjuvant setting, or in the context of multimodal therapy for locally advanced disease, should have PD within 6 months of the last dose of platinum-containing therapy.

A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT

Participants will be randomized 1:1 to cretostimogene grenadenorepvec after TURBT (Arm A) vs observation after TURBT (Arm B). Participants in Arm A will receive an induction course and then quarterly maintenance courses of cretostimogene through Month 13, if there is no disease recurrence. Disease status will be assessed using urine cytology, complete bladder visualization (e.g., cystoscopy), and directed TURBT/biopsy (if indicated) every 3 months for the first 2 years after randomization and then every 6 months for an additional year or until disease recurrence. Participants in Arm B who recur with IR-NMIBC after TURBT and observation will be offered treatment with cretostimogene as per the treatment schedule in Arm A.