An Open-label, DDI Study to Investigate the Effects of Amlitelimab on the PK of Selected Cytochrome P450 Substrates

Conditions

• Dermatitis Atopic

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Amlitelimab — DRUG
  Pharmaceutical form: Injection solution Route of administration: SC injection
• Midazolam — DRUG
  Pharmaceutical form: Solution Route of administration: Oral
• Caffeine — DRUG
  Pharmaceutical form: Tablet Route of administration: Oral
• Metoprolol — DRUG
  Pharmaceutical form: Tablet Route of administration: Oral
• Omeprazole — DRUG
  Pharmaceutical form: Capsule Route of administration: Oral
• Warfarin — DRUG
  Pharmaceutical form: Tablet Route of administration: Oral

Study Details

This is an open-label, single group, 2-period, Phase 1, single-sequence study. The study duration will be up to 342 days. The treatment period will be up to Week 29, where Week 29 is defined as End of Treatment (last amlitelimab administration at Week 25). The number of visits will be 23 or 21 visits for participants who decide to continue amlitelimab therapy in the long-term extension study LTS17367 (RIVER-AD) study.

Key Dates

First listed

Nov 13, 2024

Start date

Nov 20, 2024

Status verified

Apr 2026

Primary completion

Nov 21, 2025

Completion

Apr 2, 2026

Study Design

Enrollment

23 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Amlitelimab and CYP substrates
  A single oral dose of a CYP450 substrates cocktail which will include caffeine, metoprolol, midazolam, omeprazole, and warfarin will be administered. A single dose of amlitelimab will then be administered on several days. A single oral dose of CYP450 substrates cocktail in combination with the last single dose of amlitelimab.

Primary Outcome Measure

AUC and AUClast for CYP substrates [ Time Frame: Baseline (Day 1 to Day 8) and Day 176 to Day 183 ]