NCT04626414

Four-Way Crossover Study to Compare Ferric Maltol Capsules and Oral Suspension in Healthy Volunteers

A Randomized, Open-Label, Single Dose, Four-Way Crossover, Phase I Study to Compare the Pharmacokinetics of Ferric Maltol Capsules and Oral Suspension Under Fasted and Fed Conditions in Adult Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Shield Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to compare the Pharmacokinetics (PK) of the new ferric maltol suspension, in adults, with the existing ferric maltol capsule.

Detailed description

Open-label, Phase 1, four way crossover study to compare the PK of the new ferric maltol suspension, in healthy volunteers, with the existing ferric maltol capsules under fed and fasted conditions. 32 subjects will be randomised to 1:1:1:1 ratio to receive one of the treatment sequences. Based on the randomised sequence, subjects will receive a single dose of 30mg ferric maltol capsule in a fed/ fasted condition and 30 mg (5ml) ferric maltol suspension in a fed/ fasted condition. Subject participation in the study will consist of 3 periods: 1. Screening: up to 14 days 2. Randomised treatment: 8 days 3. Post-treatment follow up: 3-7 days following drug discontinuation

Conditions

• Anemia, Iron Deficiency

Interventions

Type	Name	Description
DRUG	Ferric maltol capsule	single dose of 30 mg capsule
DRUG	Ferric maltol suspension	single dose of 30mg (5ml) oral suspension

Timeline

• Start date: 2020-09-28
• Primary completion: 2020-11-13
• Completion: 2020-11-13
• First posted: 2020-11-12
• Last updated: 2025-08-24
• Results posted: 2025-08-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study