PPD Phase I Clinic
Austin, Texas, 78744, United States
NCT Number: NCT05930925
The purpose of the study is to understand how the study medicine ARV-471 is processed in the body of healthy males and females who do not have the potential to have children.
This study is seeking for participants who:
* are healthy males and females who do not have the potential to have children. * are 18 years of age or older. * weigh more than 110 pounds.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 1
Austin, Texas, 78744, United States
About 6 participants each will receive a single dose of either type of ARV-471. They are taken as liquid suspensions by mouth. Participants will stay in the study site for about 13 days and 12 nights.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive a single dose of [phenyl-14C]ARV-471 by mouth
Participants will receive a single dose of [oxoisoindolin-14C]ARV-471 by mouth
Time frame: Day 1 pre-dose, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 hours post-dose
Time frame: Day 1 pre-dose, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 hours post-dose
Time frame: Day 1 pre-dose, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 hours post-dose
Time frame: Day 1 pre-dose, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 hours post-dose
Time frame: Day 1 pre-dose, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 hours post-dose
Time frame: Day 1 pre-dose, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 hours post-dose
Time frame: Day 1 pre-dose, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 hours post-dose
Time frame: Day 1 at intervals of 0-6 hours, 6-12 hours, 12-24 hours, and at each subsequent 24-hour interval starting on Day 2 until Day 12 or the discharge day
Time frame: Day 1 at intervals of 0-6 hours, 6-12 hours, 12-24 hours, and at each subsequent 24-hour interval starting on Day 2 until Day 12 or the discharge day
Time frame: Day 1 pre-dose, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 hours post-dose
Time frame: Day 1 pre-dose, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 hours post-dose
Time frame: Day 1 pre-dose, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 hours post-dose
Time frame: Day 1 pre-dose, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 hours post-dose
Time frame: Day 1 pre-dose, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 hours post-dose
Time frame: Day 1 pre-dose, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 hours post-dose
Time frame: Day 1 pre-dose, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 hours post-dose
Time frame: Starting on Day 1 to Day 12 or the discharge day
Time frame: Day 1 pre-dose, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 hours post-dose
Time frame: Time the participant provides informed consent through and including follow-up contact occurring 28 to 35 calendar days after the last administration of the study intervention.
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. SAE is defined as one of the following: is fatal or life-threatening; results in persistent or significant disability/incapacity; constitutes a congenital anomaly/birth defect; is medically significant; requires inpatient hospitalization or prolongation of existing hospitalization. Treatment-emergent AE is defined as an AE with onset date occurring during the on-treatment period. AEs include all SAEs and non-SAEs.
Time frame: Baseline up to Day 12/Discharge
Following parameters were analyzed for laboratory examination: hematology(hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); liver function(aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid, cystatin C);electrolytes (sodium, potassium, chloride, calcium, bicarbonate); clinical chemistry(glucose); urinalysis (dipstick[decimal logarithm of reciprocal of hydrogen ion activity {pH} of urine, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, bilirubin], microscopy.
Time frame: Baseline up to Day 12/Discharge
ECG abnormalities criteria include a) a post dose QTcF is increased by >60 ms from the baseline and is >450 ms; or b) an absolute QTcF value is >500ms for any scheduled ECG.
Time frame: Baseline up to Day 12/Discharge
Blood pressure and pulse rate will be performed following at least a 5-minute rest in a supine position.
Time frame: Baseline up to Day 12/Discharge
A complete physical examination will include, at a minimum, head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, and gastrointestinal, musculoskeletal, and neurological systems.
Pfizer
Industry
AN INTERVENTIONAL, PHASE 1, OPEN-LABEL, 2-ARM PARALLEL STUDY TO INVESTIGATE THE ABSORPTION, METABOLISM, AND EXCRETION OF [14C]ARV-471 IN HEALTHY ADULT PARTICIPANTS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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