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

Healthy Volunteers Clinical Trial

Official title:

A First-in-human, Randomized, Participant and Investigator Blinded, Placebo Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of EDI048 in Healthy Volunteers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05275855
• Other study ID #: CEDI048A02101
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: April 29, 2022
• Est. completion date: November 28, 2024

Study information

• Verified date: November 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 54
• Est. completion date: November 28, 2024
• Est. primary completion date: November 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• EDI048
Oral Liquid

Other:
• Placebo
Oral Liquid

Locations

Country	Name	City	State
United Kingdom	Novartis Investigative Site	Mere Way	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Adverse Events (AEs)	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.	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
Secondary	Parts A and B: Cmax	Characterize the Cmax profile following EDI048 dosing	up to 13 days
Secondary	Parts A and B: Tmax	Characterize the Tmax profile following EDI048 dosing	up to 13 days
Secondary	Parts A and B: AUClast	Characterize the AUClast profile following EDI048 dosing	up to 13 days
Secondary	Parts A and B: AUCinf	Characterize the AUCinf profile following EDI048 dosing	up to 13 days
Secondary	Parts A and B: T1/2	Characterize the T1/2 profile following EDI048 dosing	up to 13 days
Secondary	Part B: AUC0-12h	Characterize the AUC0-12h profile following EDI048 dosing	up to 13 days
Secondary	Part B: Accumulation (Racc)	Characterize the Racc profile following EDI048 dosing	up to 13 days
Secondary	Part A: Renal Clearance (CLr)	Characterize the CLr profile following EDI048 dosing	up to 13 days
Secondary	Part A: Ae0-t	Assess amount of EDI048 excreted in urine	up to 3 day