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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04529811




Registration number
NCT04529811
Ethics application status
Date submitted
25/08/2020
Date registered
28/08/2020
Date last updated
18/06/2021

Titles & IDs
Public title
Randomised, Placebo-controlled Safety and Pharmacokinetics Study of Novel Rifaximin Formulations in Healthy Volunteers
Scientific title
A Randomised, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Novel Rifaximin Formulations in Healthy Volunteers
Secondary ID [1] 0 0
RBPK1001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rifaximin Novel Formulation
Treatment: Drugs - Placebo

Experimental: Formulation 1 - Low Dose - Rifaximin Formulation 1 Capsules

Experimental: Formulation 1 Capsules - Mid Dose - Rifaximin Formulation 1 Capsules

Experimental: Formulation 1 Capsules - High Dose - Rifaximin Formulation 1 Capsules

Experimental: Formulation 1 Capsules - Max Dose - Rifaximin Formulation 1 Capsules

Placebo Comparator: Formulation 1 Capsules - Placebo - Placebo Formulation 1 Capsules

Experimental: Formulation 2 - Low Dose - Rifaximin Formulation 2 Capsules

Experimental: Formulation 2- Mid Dose - Rifaximin Formulation 2 Capsules

Experimental: Formulation 2 - High Dose - Rifaximin Formulation 2 Capsules

Experimental: Formulation 2 - Max Dose - Rifaximin Formulation 2 Capsules

Placebo Comparator: Formulation 2 - Placebo - Placebo Formulation 2 Capsules

Experimental: Formulation 3 - Low dose - Rifaximin Formulation 3 Capsules

Experimental: Formulation 3 - Mid dose - Rifaximin Formulation 3 Capsules

Experimental: Formulation 3 - High dose - Rifaximin Formulation 3 Capsules

Experimental: Formulation 3 - Max dose - Rifaximin Formulation 3 Capsules

Placebo Comparator: Formulation 3 - Placebo - Placebo Formulation 3 Capsules


Treatment: Drugs: Rifaximin Novel Formulation
Rifaximin Novel Formulation

Treatment: Drugs: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of participants with adverse events
Timepoint [1] 0 0
Up to 18 days

Eligibility
Key inclusion criteria
- 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).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/05/2021
Sample size
Target
Accrual to date
Final
124
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bausch Health Americas, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04529811
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christian Schwabe, MD
Address 0 0
Auckland Clinical Studies
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries