First in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of EDI048 in Healthy Volunteers

Phase 1

Recruiting

• Conditions: Healthy Volunteers
• Interventions: Drug: EDI048; Other: Placebo

• Registration Number: NCT05275855
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

A first-in-human study to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses and multiple ascending doses of EDI048 administered orally in healthy volunteers.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-03-02
• Study First Submitted QC: 2022-03-10
• Study First Posted: 2022-03-11
• Study Start: 2022-04-29
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-09
• Primary Completion: 2024-12-12
• Study Completion: 2024-12-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Healthy male and female participants 18 to 55 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
• Participants must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18.0 - 30.0 kg/m2. BMI = Body weight (kg) / [Height (m)]2
• At screening and baseline, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the supine position after the participant has rested for at least three (3) minutes, and again in the standing position. Supine vital signs should be within the following ranges:
• oral body temperature between 35.0-37.5 °C
• systolic blood pressure, 90-139 mmHg
• diastolic blood pressure, 50-89 mmHg
• pulse rate, 40-90 bpm

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Exclusion Criteria

• Participants who have received any IMP in a clinical research study within 90 days or 5 half-lives of enrollment, whichever is longer; or longer if required by local regulations.
• History of multiple and recurring allergies or allergy or hypersensitivity to any of the study treatments, excipients or drugs of similar chemical classes. Hay fever is allowed unless it is active at time of screening or if there is a risk that it may become active during the study.
• Pregnant or nursing (lactating) women, assessed at screening and baseline.
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
• Sexually active males unwilling to use a condom during intercourse while taking investigational drug and for 7 days after stopping the investigational drug.

Additional protocol-defined inclusion / exclusion criteria may apply.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part A: EDI048 or Placebo	EDI048	Part A is a single ascending dose study
Part A: EDI048 or Placebo	Placebo	Part A is a single ascending dose study
Part B: EDI048 or Placebo	EDI048	Part B is a multiple ascending dose study
Part B: EDI048 or Placebo	Placebo	Part B is a multiple ascending dose study

Primary Outcome Measures

Name	Time	Method
Number of participants with Adverse Events (AEs)	From the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 8.5 weeks for Part A and 9 weeks for Part B	Number of participants with AEs and Serious Adverse Events (AEs), including significant changes from baseline in vital signs, electrocardiograms and laboratory assessments qualifying and reported as AEs.

Secondary Outcome Measures

Name	Time	Method
Parts A and B: AUClast	up to 13 days	Characterize the AUClast profile following EDI048 dosing
Parts A and B: T1/2	up to 13 days	Characterize the T1/2 profile following EDI048 dosing
Part B: Accumulation (Racc)	up to 13 days	Characterize the Racc profile following EDI048 dosing
Parts A and B: Cmax	up to 13 days	Characterize the Cmax profile following EDI048 dosing
Parts A and B: Tmax	up to 13 days	Characterize the Tmax profile following EDI048 dosing
Parts A and B: AUCinf	up to 13 days	Characterize the AUCinf profile following EDI048 dosing
Part B: AUC0-12h	up to 13 days	Characterize the AUC0-12h profile following EDI048 dosing
Part A: Renal Clearance (CLr)	up to 13 days	Characterize the CLr profile following EDI048 dosing
Part A: Ae0-t	up to 3 day	Assess amount of EDI048 excreted in urine

Trial Locations

Locations (1)

Novartis Investigative Site; 🇬🇧 Mere Way, Nottingham, United Kingdom