Multiple Ascending Dose Phase I Study in Order to Define Lanifibranor (IVA337) Supra-thjerapeutic Dose

NCT03866369 | Completed Phase 1 DMC

• 2 other identifiers: 337HVPK180072018-003822-99
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The study will be a double-blind, randomized, placebo-controlled, multiple ascending dose study with lanifibranor. The study will consist of up to 3 cohorts of 12 subjects each; therefore, approximately 36 subjects will be included in this study.

Conditions

Healthy Subjects

Keywords

healthy male volunteers; multiple ascending dose; supra-therapeutic dose

Outcome Measures

Primary Outcomes (4)

• Number of Adverse events

  From Baseline up to 15 days

• Number of abnormal Vital signs (blood pressure, pulse) and physical exams

  From Baseline up to 15 days

• Number of abnormal Clinical laboratory tests (chemistry, hematology, urinalysis)

  From Baseline up to 15 days

• Number of abnormal 12-lead digital electrocardiograms parameters (Heart rate, QT/QTc interval, PR interval, QRS interval, RR interval) change from baseline

  From Baseline up to 15 days

Secondary Outcomes (4)

• Maximum plasma concentration (Cmax) of lanifibranor and its metabolites

  15 days

• Time of maximum plasma concentration (Tmax) of lanifibranor and its metabolites

  15 days

• Area under the concentration-time curve (AUC0-t) of lanifibranor and its metabolites

  From Baseline up to 15 days

• Number of Cardiovascular safety events

  From Baseline up to 15 days

Study Arms (2)

Experimental

EXPERIMENTAL

IMP Under investigation

Drug: Moxifloxacin; Drug: Placebo; Drug: Lanifibranor

Placebo to Match

PLACEBO COMPARATOR

Drug: Moxifloxacin; Drug: Placebo

Interventions

Moxifloxacin DRUG

Single oral dose at D-8

Experimental; Placebo to Match

Placebo DRUG

Single oral dose at D-1

Experimental; Placebo to Match

Lanifibranor DRUG

Single daily oral dose during 14 days

Experimental

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject voluntarily agrees to participate in this study and signs an IEC-approved informed consent prior to performing any of the Screening Visit procedures.
• \. Males between 18 to 55 years of age (inclusive) 3. Nonsmokers (or other nicotine use) as determined by history (no nicotine use over the past 3 months) and by urine cotinine concentration (\< 500 ng/mL) at the Screening Visit and admission.
• \. Body mass index (BMI) between 18.0 and 29.9 kg/m2 (inclusive) at the Screening Visit.
• \. Healthy with no clinically relevant deviation or finding in medical history, physical examinations, vital signs or 12-lead ECGs at the Screening Visit or admission, as applicable. Clinical laboratory values at the Screening Visit or admission should be within normal limits or judged not clinically significant as determined by the Investigator and with liver values such as:
• Alanine aminotransferase (ALT) ≤ 1.1 x upper limit of normal (ULN)
• Aspartate aminotransferase (AST) ≤ 1.2 × ULN
• Gamma-glutamyltransferase (GGT) ≤ 1.5 × ULN
• Alkaline phosphatase (ALP) ≤ 1.5 × ULN

You may not qualify if:

• History or evidence of any relevant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic (e.g., diabetes), urologic, pulmonary, neurologic, psychiatric, dermatologic, renal (e.g., renal insufficiency), and/or other major disease or malignancy (e.g., bladder cancer) or present infectious disease as judged by the Investigator.
• Subject has any surgical or medical condition that would interfere with the absorption, distribution, metabolism or excretion of drugs, or which may jeopardize the subject in case of participation in the study.
• Inflammatory bowel disease, peptic ulcers, gastrointestinal including rectal bleeding.
• Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection.
• Pancreatic injury or pancreatitis within 12 months prior to Screening.
• Liver disease or liver injury as indicated by abnormally increased liver function tests. ALT, AST, GGT, ALP, and serum bilirubin will be tested at Screening.
• Any single parameter of ALT, AST, GGT, or ALP must not exceed 1.1 x ULN and ≥ 1.2 x ULN total bilirubin.
• Any elevation above ULN of more than one parameter of ALT, AST, GGT, ALP, or serum bilirubin will exclude a subject from participation in the study.
• If necessary, laboratory testing may be repeated on one occasion (as soon as possible) prior to randomization, to rule out any laboratory error.
• History or presence of impaired renal function as indicated by clinically significantly abnormal creatinine or blood urea nitrogen and/or urea values, or abnormal urinary constituents (e.g. albuminuria).
• Evidence of urinary obstruction or difficulty in voiding
• History of immunodeficiency diseases.
• Blood levels of sodium, potassium, calcium, or magnesium outside of laboratory normal range at Screening and baseline.
• TSH outside of laboratory normal range at Screening.
• Subject has any concurrent disease or condition that, in the opinion of the Principal Investigator, would make the subject unsuitable for participation in the clinical study.

Sponsors & Collaborators

• Inventiva Pharma: lead
• Parexel: collaborator

Study Sites (1)

Parexel International GmbH

Berlin, Germany

Location

MeSH Terms

Interventions

Moxifloxacin; lanifibranor

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multiple ascending dose study with 3 sequential cohorts of 12 subjects treated by Lanifibranor versus Placebo during 14 days

Study Record Dates

• First Submitted: March 1, 2019
• First Posted: March 7, 2019
• Study Start: January 17, 2019
• Primary Completion: August 27, 2019
• Study Completion: August 27, 2019
• Last Updated: November 1, 2019

Record last verified: 2019-10

Locations

DE (1)