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NCT ID: NCT06012721 Completed - Clinical trials for Food Effect in Healthy Participants

Effect of Food on the Pharmacokinetics of ORIC-114

Start date: September 11, 2023
Phase: Phase 1
Study type: Interventional

A randomized, 2-part, 2-sequence, 2-period, open-label, crossover study evaluating the effect of food on the pharmacokinetics (PK) of ORIC-114 tablet formulation in healthy adult subjects.

NCT ID: NCT05979207 Completed - Inflammation Clinical Trials

Phase 1b MMV367 PK/PD and Safety in Healthy Adult Volunteers Experimentally Infected With Blood Stage P. Falciparum

Start date: August 1, 2023
Phase: Phase 1
Study type: Interventional

This is an open-label, adaptive study using the P. falciparum induced blood stage malaria (IBSM) model to characterise the pharmacokinetic/pharmacodynamic (PK/PD) profile and safety of MMV367 (the IMP). Up to 18 participants will be enrolled in cohorts of up to 6 participants each. The study will proceed as follows for all participants: - Screening period of up to 28 days to recruit healthy adult participants. - Day 0: Intravenous inoculation with approximately 2,800 viable P. falciparum-infected red blood cells. - Days 1-3: Daily follow up via phone call or text message. - Days 4-7: Daily site visits for clinical evaluation and blood sampling to monitor malaria parasite numbers via quantitative polymerase chain reaction (qPCR). - Day 7 PM: Start of confinement within the clinical trial unit. - Day 8: Administration of a single oral dose of the IMP (MMV367). Different doses of MMV367 will be administered across and within cohorts in order to effectively characterise the PK/PD relationship. - Days 8-11: Regular clinical evaluation and blood sampling while confined to monitor malaria parasite numbers and measure MMV367 plasma concentration. - Day 11 AM: End of confinement within clinical trial unit. - Days 12-23: Outpatient follow-up for clinical evaluation and blood sampling. - Day 24: Initiation of compulsory definitive antimalarial treatment with Riamet® (artemether/lumefantrine) and/or other registered antimalarials if required. Treatment will be initiated earlier than Day 24 in the event of: - Insufficient parasite clearance following IMP dosing - Parasite regrowth following IMP dosing Characterising the pharmacokinetic/pharmacodynamic relationship of MMV367 - Participant discontinuation/withdrawal, - Investigator's discretion in the interest of participant safety. - Day 27: End of study visit for final clinical evaluation and to ensure complete clearance of malaria parasites.

NCT ID: NCT05941247 Completed - Healthy Clinical Trials

A Study to Evaluate the Effects of Single and Multiple Doses of Hemay005 Tablets in Health Caucasian Adult Volunteers

Start date: July 17, 2023
Phase: Phase 1
Study type: Interventional

The purpose of the study is to assess the safety and tolerability of single and multiple oral doses of Hemay005 tablets in healthy Caucasian adult volunteers.

NCT ID: NCT05936502 Completed - Clinical trials for Head and Neck Squamous Cell Carcinoma

Ascertaining the Radiologic Prognostic Importance of Extranodal Extension on Imaging (iENE) in Head and Neck Cancer

EPIC-iENE DATA
Start date: July 11, 2022
Phase:
Study type: Observational

Extranodal extension (ENE) refers to the spread of head and neck squamous cell carcinoma (HNSCC) outside the lymph nodes. It is a well-known factor that indicates a poorer prognosis and outcome for patients who have undergone surgical removal of the cancer. In such cases, it is recommended to combine chemotherapy with radiation therapy after surgery. As the number of cases of HNSCC related to the human papillomavirus (HPV) is increasing, treatment approaches have shifted towards using radiation therapy as the primary treatment method instead of surgery. This raises an important question about the significance of ENE observed through imaging tests (referred to as iENE) and its impact on the prognosis. Unfortunately, this question remains unanswered. The objective of this project is to conduct a comprehensive study across multiple medical institutions. The investigators will gather data including scan results, histopathology reports, and data from patient charts from individuals who have been treated for head and neck cancer. The aim is to analyze and correlate the findings between the pathological evidence of ENE and the imaging results, while also assessing the prognostic value of iENE. Additionally, the investigators will explore the influence of HPV status on these factors. By collecting and analyzing this data, the investigators hope to establish standardized criteria that can assist radiologists in accurately identifying ENE through imaging tests. This research is essential for enhancing our understanding of HNSCC and improving the effectiveness of diagnostic procedures and treatment planning.

NCT ID: NCT05914909 Completed - Clinical trials for Chronic Kidney Diseases

Safety, Tolerability, PK and PD Study of AD-214 Administered to Healthy Volunteers and Patients With Interstitial Lung Disease or Chronic Kidney Disease

Start date: July 17, 2023
Phase: Phase 1
Study type: Interventional

This is a Phase I, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of a 10 mg/kg dose of AD-214 when administered to healthy volunteers (HVs) (Part A) or patients with interstitial lung disease (ILD) or chronic kidney disease (CKD) (Part B). The study will be performed in Australia at up to two clinical sites.

NCT ID: NCT05897515 Completed - Clinical trials for Coronavirus Disease 2019

LIAISON NES Influenza (FLU) A/B & Coronavirus Disease 2019 (COVID-19) Clinical Agreement in Australia

Start date: June 19, 2023
Phase: N/A
Study type: Interventional

The DiaSorin Molecular LIAISON® NES FLU A/B & COVID-19 real-time polymerase chain reaction (RT-PCR) assay is intended for use on the DiaSorin LIAISON® NES instrument for the in-vitro qualitative detection and differentiation of nucleic acid from influenza A, influenza B and SARS-CoV-2 virus from dry nasal swabs (NS) from human patients with signs and symptoms during the acute phase of respiratory tract infection in conjunction with clinical and epidemiological risk factors. The LIAISON® NES FLU A/B & COVID-19 assay is intended for use as an aid in the differential diagnosis of influenza A, influenza B and SARS-CoV-2 infection in a professional laboratory setting. Negative results do not preclude influenza A, influenza B, or SARS-CoV-2, infection and should not be used as the sole basis for patient management decisions. The assay is not intended to detect the presence of the influenza C virus.

NCT ID: NCT05896969 Completed - Clinical trials for Elevated Low-Density Lipoprotein Cholesterol

Dose Escalation of SNK-396 in Participants With Elevated Low-Density Lipoprotein Cholesterol

Start date: April 27, 2023
Phase: Phase 1
Study type: Interventional

This is a Phase 1, multi-center, randomized, double-blinded, placebo-controlled single and multiple dose escalation study with SC doses of SNK-396 in participants with elevated LDL-C. The study will be divided into two parts: - SAD cohorts - MAD cohorts

NCT ID: NCT05890118 Completed - Healthy Volunteers Clinical Trials

Study Evaluating PK of Ustekinumab Administered Orally Via RaniPillâ„¢ Capsule

Start date: August 30, 2023
Phase: Phase 1
Study type: Interventional

A prospective, single-center, open-label, phase 1 study evaluating the pharmacokinetics (PK) of ustekinumab administered via the RaniPillâ„¢ capsule ("RT-111").

NCT ID: NCT05888519 Completed - Dry Eye Disease Clinical Trials

Evaluation of Safety and Tolerability of Investigational Ocular Lubricants

Start date: July 24, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate investigational ocular lubricants for their safety and tolerability on subjects with mild to moderate dry eye disease.

NCT ID: NCT05886023 Completed - Clinical trials for Health Risk Behaviors

Nitrate INFORMER Vegetable Study

Start date: June 26, 2023
Phase: N/A
Study type: Interventional

Nitrate is a controversial component of vegetables, meat, and drinking water. The now well-established benefits of nitrate, through the enterosalivary nitrate-nitrite-nitric oxide (NO) pathway, on cardiovascular risk factors and long-term cardiovascular disease risk are tarnished by a continuing concern about a link between nitrate ingestion and cancer. This can result in misguided advice to avoid consumption of high-nitrate leafy green vegetables by both the media and the scientific literature. A recent media headline stated, "Cancer alert over rocket: trendy salad leaves exceed safe levels of carcinogenic nitrates in one in every ten samples". One scientific review stated, "the presence of nitrate in vegetables, as in water and generally in other foods, is a serious threat to man's health". Controversy in the literature, and gaps in the knowledge are leading to confusing messages around vegetables that may play a critical role in cardiovascular health. The major dietary sources of nitrate are vegetables, meat, and drinking water. Source of nitrate could be a crucial factor determining whether the consumption of nitrate is linked with beneficial (such as improving cardiovascular health) versus harmful (N-nitrosamine formation) effects. For example, unlike meat and water-derived nitrate, vegetables contain high levels of vitamin C and/or polyphenols that may inhibit the production of N-nitrosamines. So far, no study has investigated the formation of N-nitrosamines after consumption of these different sources in humans. This study will compare N-nitrosamine formation after intake of vegetables with high nitrate content and vegetables with a low nitrate content.