Phase 1 N=6 Mass-balance Study of [14C]-APD421 in Healthy Volunteers
Post-operative Nausea and Vomiting
Primary: Mass Balance — 96.4 percent excreted
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Phase 1 N=5 Study to Investigate the Mass Balance, Metabolism, and Excretion of [14C]-PF-07304814 in Healthy Participants
Healthy
Primary: The Mean (SD) Amount of [14C] Recovered in Urine, as a Percent of the Total [14C] Dose Administered — 25.2 percentage of dose
Phase 1 N=22 Mass Balance and Absolute Bioavailability Study of RO7049389 in Healthy Volunteers
Healthy Volunteers
Primary: Percentage of Dose Excreted in Urine - MB Cohort — 3.81 Percentage
Phase 1 N=56 Dose-finding Pharmacokinetic Study in Healthy Males
Healthy Volunteers
Primary: Levodopa Area Under the Concentration-time Curve From Time 0 to the 24 h PK Sample (AUC0-24) Time 0 to the 24 h PK Sample (AUC0-24) — 4300; 5423; 7439; 9046 h*ng/ml
Phase 1 N=6 Metabolism and Pharmacokinetics of [14C]-BI 409306 After Administration as Oral Solution in Healthy Male Volunteers
Healthy
Primary: Mass Balance Recovery of Total Radioactivity in Urine and Faeces: Amount Excreted Within the Time Interval From 0 to the Time of the Last Quantifiable Data Point as a…
Phase 1 N=5 A Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]INCB099280 in Healthy Male Participants
Healthy Participants
Primary: Total Recovery (Urine + Feces) of the Administered Radioactivity — 83.2 percentage of radioactivity
Phase 1 N=8 Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of CT1812 in Healthy Adult Male Subjects
Alzheimer Disease
Primary: Plasma CT1812 Concentration at 96 Hours Timepoint — 0.0000707 μg/mL
Phase 1 N=8 Study Evaluating the Pharmacokinetic and Mass Balance of Single Dose [14C] AZD9291 in Volunteers
Healthy Volunteers
Primary: Percentage of Radioactive Dose of [14C] Radiolabelled AZD9291 Recovered in Urine, Faeces, and in Total. — 14.2; 67.8; 81.9 Percentage radioactive dose recovered
Phase 1 N=16 This Study Tests BI 1467335 in Healthy Male Volunteers. The Study Tests How Different Doses of BI 1467335 Are Taken up and Handled by the Body
Healthy
Primary: Fraction of [14C]-Radioactivity Excreted in Urine as Percentage of the Administered Oral Dose Over the Time Interval From 0 to the Last Quantifiable Time Point…
Early Phase 1 N=6 Single Dose ADME Study of [14C]-Rencofilstat in Healthy Male Subjects
NASH With Fibrosis
Primary: To Determine the Mass Balance Recovery After a Single Oral Dose of [14C]-Rencofilstat — 91 percentage of total radioactivity
Phase 1 N=6 A Study To Evaluate The Pharmacokinetics, Excretion, Mass Balance and Metabolism of PF-07265803
Healthy
Primary: Total Recovery of Radioactivity in Urine, Expressed as Percentage of Total Radioactive Dose Administered — 13.98 Percentage of total radioactive dose
Phase 1 N=5 Pharmacokinetics and Metabolism of 14 Carbon [14C]-GSK3640254
HIV Infections
Primary: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) in Plasma Following Administration of Oral Dose of…
Phase 1 N=8 A Study in Healthy Men to Test How BI 1569912 is Processed in the Body
Healthy
Primary: Fraction Excreted in Urine as Percentage of the Administered Dose Over the Time Interval From 0 to the Last Quantifiable Time Point (fe Urine,0-tz) of…
Phase 1 N=6 A Study to Assess Absolute Bioavailability (ABA) of TAK-831 and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of [14C]TAK-831 in Male Healthy Participants
Healthy Volunteers
Primary: Period 1: Percent Absolute Bioavailability (%F) for TAK-831 — 17.34 percent absolute bioavailability
Phase 1 N=6 Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-MD1003 in Healthy Male Subjects
Healthy Volunteers
Primary: Mass Balance Recovery of Total Radioactivity: CumAe (Urine) — 70.9 mg equiv
Phase 1 N=6 A Study in Healthy Men to Test How BI 730357 is Processed by the Body
Healthy
Primary: Mass Balance Recovery of Total [14C]-Radioactivity in Urine (Feurine, 0-tz) — 34.3 Percentage of administered dose (%)
Phase 1 N=6 An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 9-1067 and Metabolites
Parkinson's Disease (PD)
Primary: Cumulative Recovery of [14C]-Radioactivity — 12.8; 67.2; 15.9; 95.9 Recovery % of dose
Phase 1 N=6 A Study to Evaluate the Mass Balance, Pharmacokinetics (PK), Metabolism and Excretion of TAK-954 Containing Microtracer ([14C]-TAK-954) in Healthy Male Participants
Healthy Volunteers
Primary: Cumulative Percentage of Administered Radioactivity Recovered in Urine — 55.4; 56.8; 55.1 percentage of radioactive dose
Phase 1 N=6 Absorption and Elimination of Radiolabeled Daprodustat
Anaemia
Primary: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-Inf]) of Total Drug-related Material (Radioactivity) in Plasma…
Phase 1 N=6 Study to Assess Absolute Bioavailability of TAK-935 (OV935) and to Characterize Mass Balance, Pharmacokinetics, Metabolism, and Excretion of [14C]TAK-935 (OV935) in Healthy Male Participants
Healthy Volunteers
Primary: Period 1: Percent Absolute Bioavailability (%F) for TAK-935 — 12.57 percent absolute bioavailability
Phase 1 N=24 A Study in Healthy Men to Test How BI 764198 is Processed in the Body
Healthy
Primary: Mass Balance Recovery of Total Radioactivity in Urine and Faeces: Amount Excreted Within the Time Interval From 0 to the Time of the Last Quantifiable Data Point as a…
Phase 1 N=6 Study to Assess Absolute Bioavailability (ABA) of TAK-906 and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of [14C]-TAK-906 in Healthy Male Participants
Healthy Volunteers
Primary: Period 1: Absolute Bioavailability Based on Ratio of Dose Normalized Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC∞ ) for TAK-906 — 9.12…
Phase 1 N=17 An Open-label, Multiple-dose, Single-centre Study, Investigating the Pharmacokinetics of BIA 2-093
Epilepsy
Primary: Area Under the Plasma Concentration Versus Time Curve, AUC(0-tlast). — 954.891; 49.750; 240188.369; 234750.429 h·ng/mL
Phase 1 N=8 A Study in Healthy Men to Test How BI 1291583 is Processed in the Body
Healthy
Primary: Mass Balance and Total Recovery of [14C]-Radioactivity in Urine: Fraction of [14C]-Radioactivity Excreted in Urine Expressed as Percentage of the Administered Dose Over…
Phase 1 N=7 Single Dose Study of [14C]-IDV184001AN ([14C]-IDV184001) in Healthy Adult Male Participants
Opioid Use Disorder
Primary: Percent of Radioactive Dose Excreted in the Urine, Feces, and Urine+Feces (%Dose) Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants…
Phase 1 N=3 Mass Balance, Pharmacokinetics and Metabolism Study of Alisertib
Advanced Solid Tumors · Lymphoma
Primary: Cmax: Maximum Observed Plasma Concentration for Alisertib and Drug-Related Material Following a Single Dose of [^14C]-Alisertib Oral Solution — 2183.3; 2606.7 nanomole…
Phase 1 N=16 Study on Sapropterin Dihydrochloride Oral Suspension in Healthy Subjects
Bioavailability
Primary: Uncorrected Sapropterin AUC0-t — 989.77; 837.20; 835.52; 791.64 hr*ng/mL
Phase 1 N=62 Study to Assess the Effect of Sodium Zirconium Cyclosilicate on the Pharmacokinetics of Tacrolimus and Cyclosporin in Healthy Subjects
Hyperkalaemia
Primary: Maximum Observed Concentration (Cmax) — 27140; 19350; 593.6; 608.1 Picogram/milliliter (pg/ml)
Phase 1 N=42 Study on Sapropterin Dihydrochloride Oral Suspension in Healthy Subjects Under Fed Conditions
Bioequivalence
Primary: Uncorrected and Baseline-corrected Sapropterin AUCt — 819.78; 805.79; 757.73; 755.15 hr*ng/mL
Phase 1 N=48 Single-dose Study in Two Panels of Healthy Adult Participants to Assess Immediate-Release and Dispersible Formulations of Pretomanid
Multi-drug Resistant Tuberculosis
Primary: Relative Bioavailability - Cmax — 2170; 1180; 1850; 1090 ng/mL — p=0.0001