Mass Balance and Absolute Oral Bioavailability of [14C]VH4524184
ConditionHIV Infections
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorViiV Healthcare
About this trial
The purpose of the study is to assess the bioavailability, mass balance, pharmacokinetics, metabolism and excretion of radiolabeled (14C) VH4524184.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Willing and able to sign the Informed Consent Form (ICF).
Sex at birth: male or female; female participants must be of non-childbearing potential, or postmenopausal.
Age: 18 to 55 years, inclusive, at screening.
BMI: 18.0 to 32.0 kg/m², inclusive, at screening.
Disqualifiers
Employee of ICON, the Sponsor, GSK or associated vendors.
History of relevant drug and/or food allergies.
History of drug hypersensitivity, delayed-type hypersensitivity, or severe hypersensitivity reactions, as well as history of sensitivity to the study drug.
Using tobacco/nicotine products within 60 days prior to the first study drug administration.
Trial design
Design model
Single group
Treatments tested in this trial
VH4524184
DrugOne dose of VH4524184 is administered to participants at time zero on Day 1 (Period 1).
[14C]VH4524184 microdose
DrugA radiolabelled microdose of \[14C\]VH4524184 is administered 2.5 hours after VH4524184 dose administration on Day 1 (Period1).
[14C]VH4524184
DrugOne dose of radiolabelled \[14C\]VH4524184 is administered to participants at Day 15 (Period 2).
Treatment groups
9 Participants
are divided into 1 treatment groupGroup A: VH4524184 GroupExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Absolute bioavailability (F oral) of VH4524184 (Period 1)
Time frame
Day 1 up to Day 142
Amount of total radioactivity (TRA) excreted in urine (Ae urine) (Period 1)
Urine is collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and \<1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is \<1% on 2 consecutive days).
Time frame
Day 1 up to Day 143
Amount of TRA excreted in urine (Ae urine) (Period 2)
Urine is collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and \<1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is \<1% on 2 consecutive days).
Time frame
Day 15 up to Day 434
Amount of TRA excreted in feces (Ae feces) (Period 1)
Feces are collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and \<1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is \<1% on 2 consecutive days).
Time frame
Day 1 up to Day 14Secondary outcomes
1
Number of participants with adverse events (AE), overall and by severity (Periods 1 and 2)
Time frame
Day 1 to Day 502
Number of participants who discontinue treatment due to AEs (Periods 1 and 2)
Time frame
Day 1 to Day 503
Change from baseline for aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, and alkaline phosphatase (Periods 1 and 2)
Time frame
On Days 2, 14, 16, 28 and 424
Maximum toxicity grade increase from baseline for AST, ALT, total bilirubin, and alkaline phosphatase (Periods 1 and 2)
Time frame
On Days 2, 14, 16, 28 and 42Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov