Randomised, Placebo-controlled Safety and Pharmacokinetics Study of Novel Rifaximin Formulations in Healthy Volunteers

NCT04529811 | Completed Phase 1 DMC

• 1 other identifier: RBPK1001
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 1, Randomised, Placebo-Controlled, Single-Ascending Dose and Multiple-Dose with 3 novel RIFAXIMIN Formulations. 2 phases: Single-Ascending Dose (SAD) Phase and a Multiple-Dose (MD) Phase, Plus optional open-label, crossover Food Effect (FE) Evaluation Primary objective: evaluate the safety and tolerability of three novel formulations of rifaximin in healthy volunteers. Secondary objective: evaluate the pharmacokinetics (PK) of the novel formulations and to assess for the presence of exploratory biomarkers.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with adverse events

  Up to 18 days

Study Arms (15)

Formulation 1 - Low Dose

EXPERIMENTAL

Rifaximin Formulation 1 Capsules

Drug: Rifaximin Novel Formulation

Formulation 1 Capsules - Mid Dose

EXPERIMENTAL

Rifaximin Formulation 1 Capsules

Drug: Rifaximin Novel Formulation

Formulation 1 Capsules - High Dose

EXPERIMENTAL

Rifaximin Formulation 1 Capsules

Drug: Rifaximin Novel Formulation

Formulation 1 Capsules - Max Dose

EXPERIMENTAL

Rifaximin Formulation 1 Capsules

Drug: Rifaximin Novel Formulation

Formulation 1 Capsules - Placebo

PLACEBO COMPARATOR

Placebo Formulation 1 Capsules

Drug: Placebo

Formulation 2 - Low Dose

EXPERIMENTAL

Rifaximin Formulation 2 Capsules

Drug: Rifaximin Novel Formulation

Formulation 2- Mid Dose

EXPERIMENTAL

Rifaximin Formulation 2 Capsules

Drug: Rifaximin Novel Formulation

Formulation 2 - High Dose

EXPERIMENTAL

Rifaximin Formulation 2 Capsules

Drug: Rifaximin Novel Formulation

Formulation 2 - Max Dose

EXPERIMENTAL

Rifaximin Formulation 2 Capsules

Drug: Rifaximin Novel Formulation

Formulation 2 - Placebo

PLACEBO COMPARATOR

Placebo Formulation 2 Capsules

Drug: Placebo

Formulation 3 - Low dose

EXPERIMENTAL

Rifaximin Formulation 3 Capsules

Drug: Rifaximin Novel Formulation

Formulation 3 - Mid dose

EXPERIMENTAL

Rifaximin Formulation 3 Capsules

Drug: Rifaximin Novel Formulation

Formulation 3 - High dose

EXPERIMENTAL

Rifaximin Formulation 3 Capsules

Drug: Rifaximin Novel Formulation

Formulation 3 - Max dose

EXPERIMENTAL

Rifaximin Formulation 3 Capsules

Drug: Rifaximin Novel Formulation

Formulation 3 - Placebo

PLACEBO COMPARATOR

Placebo Formulation 3 Capsules

Drug: Placebo

Interventions

Rifaximin Novel Formulation DRUG

Rifaximin Novel Formulation

Formulation 1 - Low Dose; Formulation 1 Capsules - High Dose; Formulation 1 Capsules - Max Dose; Formulation 1 Capsules - Mid Dose; Formulation 2 - High Dose; Formulation 2 - Low Dose; Formulation 2 - Max Dose; Formulation 2- Mid Dose; Formulation 3 - High dose; Formulation 3 - Low dose; Formulation 3 - Max dose; Formulation 3 - Mid dose

Placebo DRUG

Placebo

Formulation 1 Capsules - Placebo; Formulation 2 - Placebo; Formulation 3 - Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant has the ability and willingness to sign a written informed consent, is either male or female aged between 18 and 65 years, inclusive, at the time of informed consent, is in good general health, and has a body mass index (BMI) at least 18 kg/m2 and at most 34 kg/m2, and a minimum body weight of 45 kg.
• The participant must have suitable venous access for blood sampling and be able and willing to complete the study and comply with all study instructions and attend the necessary visits.
• A negative pregnancy test is required for all women of child-bearing potential (WOCBP). WOCBP and men must agree to use highly effective contraception methods from screening through the end of the study. Follicle stimulating hormone (FSH) testing will be conducted for post-menopausal women without surgical evidence of sterility (total hysterectomy, bilateral oophorectomy, or bilateral tubal ligation).

You may not qualify if:

• Female participant who is pregnant, trying to become pregnant, or breast feeding.
• Participant with a known or suspected intolerance to rifaximin or the excipients used in the novel formulations.
• Participant has had any major illness or systemic infection (including COVID \[coronavirus disease\] -19) within 4 weeks of the Screening Visit or has a clinically relevant history or currently suffering from any disease or condition that, in the opinion of the Investigator, may affect the evaluation of the study product or place the participant at undue risk. Participant has liver function tests \>1.1x the upper limit of normal or any other abnormal laboratory test that the Investigator deems as clinically significant.
• Participant has human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection, a clinically relevant history of or current evidence of abuse of alcohol or other drugs. Participant is currently a tobacco smoker or was a tobacco smoker within 6 months of the Baseline Visit.
• Participant has received any investigational product within 4 weeks or 5 half-lives of the product, whichever is greater, prior to the Baseline Visit or is scheduled to receive an investigational product (other than the study product) or is scheduled for a medical procedure during the study period. Participant is taking probiotics.
• Participant is taking any medications which are known cytochrome P450 3A (CYP3A) or P-glycoprotein (Pgp) inhibitors/inducers or is currently using any medication that, in the opinion of the Investigator, may affect the evaluation of the study product or place the participant at undue risk.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (1)

Auckland Clinical Studies

Grafton, Auckland, New Zealand

Location

Study Officials

• Christian Schwabe, MD

  Auckland Clinical Studies

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: August 28, 2020
• Study Start: September 24, 2020
• Primary Completion: May 9, 2021
• Study Completion: May 9, 2021
• Last Updated: June 18, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)