4,901 trials
Hepatic Impairment
Primary: Part 1: Maximum Observed Plasma Concentration (Cmax) of NAL ER — 3.30; 7.67; 13.9; 18.7 nanogram per milliliter (ng/mL)
Esophageal Cancer · Cancer of the Esophagus
Primary: Safety as Measured by Number of Participants With Grade 3 or Higher Treatment Related Adverse Events — 1; 1; 1; 1 Participants
Food Effect in Healthy Participants
Primary: Assessment of Food Effect Based on CRS3123 PK Parameters AUC0-t, AUC0-inf, and Cmax — 129.9; 123.2; 64.9 Ratio
Uncomplicated Urinary Tract Infections · Urinary Tract Infections
Primary: Number of Participants With Microbiological Response at the Test of Cure (ToC) Visit — 10; 10; 1; 18 Participants
Advanced Solid Tumor
Primary: Number of Participants Experienced Dose Limit Toxicities (DLT) — 0; 0 Participants
Heart Failure · Fluid Overload
Primary: AUClast — 12470.092; 11684.297 ng*hr/mL
Healthy
Primary: Maximum Observed Plasma Concentration (Cmax) of Manogepix in Part-1 — 5750; 10865; 8343; 13874 ng/mL
Influenza, Human
Primary: Number of Participants Reporting Any Solicited Administration Site Events — 0; 0; 0; 0 Participants
Extensive Stage Small Cell Lung Carcinoma · Limited Stage Small Cell Lung Carcinoma · Neuroendocrine Neoplasm
Primary: Dose Limiting Toxicity (DLT) — 1; 0 Count of DLTs
Healthy Participants
Primary: Percentage of Total Radiocarbon (14C) Excreted in Urine — 11.9; 20.7 Percentage of 14C in urine
Interstitial Cystitis/Bladder Pain Syndrome
Primary: Change From Baseline for Worst Bladder Pain/Discomfort Scores Overnight / Over-the-day — -0.7; -1.6; -0.8; -1.7 score on a scale
Bacterial Infections
Primary: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 48hours (AUC0-48) of Omadacycline After IV Infusion — 8990; 13300 hours*nanograms per…
Eating Disorders
Primary: Eating Disorder Psychopathology — 3.75; 3.93; 3.71; 3.50 EDE-Q Global score — p=0.90
Metastatic Malignant Neoplasm in the Brain · Metastatic Melanoma · Mucosal Melanoma
Primary: Dose Limiting Toxicities — 0; 0; 0 Participants
Suicide, Attempted · Suicide, Ideation · Depression
Primary: Columbia Suicide Severity Rating Scale (CSSRS) - Visit 1 — 2.08; 2.37 points