CompletedPhase 1

Pharmacokinetics and Pharmacodynamics of Two Prolonged-release Formulations of Vamifeport in Healthy Adults

United Kingdom22 participantsStarted 2024-11-22

Plain-language summary

This is a phase 1, single-center, randomized, open-label study to characterize the pharmacokinetics (PK), pharmacodynamics (PD), and safety of vamifeport after multiple oral administrations of one immediate-release (IR) formulation and after single and multiple oral administrations of two prolonged-release (PR) formulation in healthy adult participants.

Who can participate

Age range18 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 60 years when providing written informed consent. * Healthy, as determined by the investigator based on review of defined assessments during Screening. * Body weight between 50 and 100 kilograms (kg) (inclusive) and body mass index within the range 18.0 to 32.0 kg per meter squared (kg/m2) (inclusive) at Screening and Day -1. Exclusion Criteria: * Any clinically relevant abnormal 12-lead ECG finding at Screening or Day -1 (as deemed by the investigator). * Serum ferritin of \< 30 nanograms per milliliter (ng/mL) or \> 300 ng/mL for assigned male at birth (AMAB) subjects or \<16 ng/mL or \> 300 ng/mL for assigned female at birth (AFAB) subjects at Screening or Day -1. * Hemoglobin \< 13 grams per deciliter (g/dL) (8.1 millimoles per liter \[mmol/L\]) for AMAB subjects or 12 g/dL (7.5 mmol/L) for AFAB subjects at Screening or Day -1. * Blood draw or donation of blood (\>= 450 mL) within 3 months before Screening, plasma from 2 weeks before Screening, or platelets from 6 weeks before Screening.

What they're measuring

Plasma concentration-time course profiles of vamifeport

Timeframe: Treatment Period (TP) 2: Before and after dosing on Day 4 (up to 12 hours), Day 8 (up to 48 hours), Before dosing on Day 5, 6, 7 TP 3: Before and after dosing on Day 13 (up to 48 hours) TP 4: Before and after dosing on Day 16 (up to 48 hours)

Maximum plasma concentration (Cmax) of first and last dose of vamifeport PR1 and PR2 in Treatment Period 2

Timeframe: TP2: Before, and up to 48 hours after, both the first and the last dose

Time to reach Cmax (Tmax) of first and last dose vamifeport PR1 and PR2 in Treatment Period 2

Timeframe: TP 2: Before, and up to 48 hours after, both the first and the last dose

Area under the plasma concentration curve from time zero to 12 hours (AUC0-12) of first and last dose of vamifeport PR1 and PR2 in Treatment Period 2

Timeframe: TP 2: Before, and up to 48 hours after, both the first and the last dose

Trough concentration (Ctrough) of first dose of vamifeport PR1 and PR2 in Treatment Period 2

Timeframe: Before and up to 24 hours after the first dose in TP2

AUC from time zero to infinity (AUC0-inf) of last dose of vamifeport PR1 and PR2 in Treatment Period 2

Timeframe: TP 2: Before, and up to 48 hours after last dose

Trial details

NCT IDNCT06726863

SponsorCSL Behring

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01-27

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