A Study to Assess the Mass Balance Recovery and Metabolite Profile & Identification of [14C]-APX001 in Healthy Males
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|ClinicalTrials.gov Identifier: NCT04804059|
Recruitment Status : Completed
First Posted : March 18, 2021
Last Update Posted : March 18, 2021
|Condition or disease||Intervention/treatment||Phase|
|Fungal Infection||Drug: [14C]-APX001 Oral Solution Drug: [14C]-APX001 Solution for Infusion||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-APX001 in Healthy Male Subjects After Oral and Intravenous Dosing|
|Actual Study Start Date :||August 17, 2018|
|Actual Primary Completion Date :||September 26, 2018|
|Actual Study Completion Date :||September 26, 2018|
Experimental: Cohort A
[14C]-APX001 Oral Solution
Drug: [14C]-APX001 Oral Solution
Total dose containing NMT 3.1 MBq (84.0 µCi) 14C
Experimental: Cohort B
[14C]-APX001 Solution for Infusion
Drug: [14C]-APX001 Solution for Infusion
Total dose containing NMT 3.4 MBq (93.0 µCi) 14C
- Mass balance recovery as measured by mass unit equiv/g after a single oral or single intravenous (IV) dose of carbon-14 (14C)-labelled APX001 ([14C]-APX001). [ Time Frame: 3 weeks ]
- Profiling of metabolites of [14C]-APX001 in plasma and excreta. [ Time Frame: 3 weeks ]Plasma, urine and feces samples from subjects dosed with [14C]-APX001 were analyzed using high resolution, accurate mass liquid chromatography tandem mass spectrometry (LC-MS/MS) with in-line fraction collection and off-line counting to obtain [14C]-radiochromatographic profiles and provide information on the nature of the radioactive components present, including chemical structure identification.
- Elimination pathway of [14C]-APX001 following a single oral or single IV dose of [14C]-APX001. [ Time Frame: 3 weeks ]Amount of radioactivity recovered from urine and feces over time was measured by liquid scintillation counting (LSC) and expressed as a percentage of administered radioactivity.
- Extent of distribution of total radioactivity into blood cells following a single oral or single IV dose of [14C]-APX001. [ Time Frame: 3 weeks ]Amount of radioactivity in whole blood over time was quantified by LSC and expressed in ng equivalents free drug/g.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04804059
|Ruddington, Nottingham, United Kingdom, NG11 6JS|