Clinical trial NCT05077436: Bioavailability Study Comparing 2 Vamifeport Oral Formulations in Fasted Versus Fed State in Healthy Subjects
Official title: A Randomised, Open-Label, Food Effect and Formulation Bioavailability Study of Two Vamifeport Oral Formulations in Healthy Male and Female Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Vifor Pharma
Sponsor class: INDUSTRY
First posted: 2021-10-14
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Two different vamifeport oral formulations will be administered in fed and fasted state to assess the vamifeport food-drug interaction and to assess the relative bioavailability (the proportion of drug entering the circulation) of 2 different vamifeport oral formulations in healthy adult participants.

Participants will be randomly allocated to one of four treatment sequences, with four dosing periods each, where different combinations of both formulations will be administered following fasted and fed state.

The total study duration for each participant is up to 7 weeks and 4 days.


Eligibility criteria: Inclusion Criteria:

* Healthy participant. Healthy status defined by the Investigator.
* A body weight between 50 and 100 kg inclusive at screening.
* Non-smokers, or former smokers.
* Both female and male participants must agree to comply with the birth control requirements for the study.
* Ability to understand the requirements of the study and abide by the study restrictions, and agreement to return for the required assessments.

Exclusion Criteria:

* History of clinically significant gastrointestinal, cardiovascular, musculoskeletal, endocrine, neurological, hematological, psychiatric, renal, hepatic, bronchopulmonary, allergic or lipid metabolism disorders, cancer, or drug hypersensitivity.
* Any clinically relevant abnormal 12-lead ECG finding during screening or prior to randomization.
* A clinically relevant history of drug or alcohol misuse or abuse within 2 years prior to screening.
* Positive qualitative or semi-quantitative test for drugs of abuse positive cotinine screen (used to detect recent nicotine use), or alcohol breath test at screening (Visit 1) or Study Day -1 (Visit 2). Use of any of these agents will be not permitted during study participation.
* Strenuous physical exercise within the 1 week prior to Visit 2/Study Day -1 admission, and until completion of safety follow-up assessments are completed.
* Female participants who are pregnant or breastfeeding.
* Any concomitant medication (including herbal remedies and vitamins) taken within 2 weeks prior to Visit 2.
* Concomitant use of hormonal contraceptives (contraception associated with inhibition of ovulation), which are metabolized through cytochrome P450 (CYP) 3A4.
* Any other investigational drug.
* Blood draw or blood donation of ≥20 to \<200 ml within 2 weeks, ≥200 to \<400 ml within 4 weeks, or ≥400 ml within 12 weeks (male) or within 16 weeks (female) prior to Visit 2.

Primary outcomes:
measure: Area under the plasma concentration versus time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC0-last) of vamifeport
timeFrame: Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose
measure: Area under the plasma concentration versus time curve from time 0 extrapolated to infinite time (AUC0-infinity) of vamifeport
timeFrame: Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose
measure: Maximum observed concentration (Cmax) of vamifeport
timeFrame: Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose
Secondary outcomes:
measure: Time of maximum vamifeport plasma concentration (Tmax)
timeFrame: Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose
measure: Apparent terminal disposition phase half-life (tl/2)
timeFrame: Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose
measure: Apparent terminal disposition phase rate constant
timeFrame: Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose
measure: Apparent total clearance
timeFrame: Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose
measure: Apparent volume of distribution during the terminal disposition phase
timeFrame: Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Labcorp Clinical Research Unit Ltd.
Study officials:
affiliation: Clinical Research Director
name: Peter Szecsödy, MD
role: STUDY_DIRECTOR
References: