Pharmacokinetics and Pharmacodynamics of Rifaximin Novel Formulations in Patients with Sickle Cell Disease

Phase 2

Conditions: Haematological Disorders

Registration Number: PACTR202206488890527

Lead Sponsor: Bausch Health America

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 60

Inclusion Criteria

1.Subject must have the ability and willingness to sign a written informed consent form.
2.Subject is between the ages of 18 to 70 years old (inclusive) at the time of consent.
3.Subject has SCD of any genotype (HbSS, HbSC, HbS ß-thalassemia). If the subject’s
genotype has not been previously documented, genotyping will be performed during
Screening using high-performance liquid chromatography (HPLC)/electrophoresis.
4.Subject must have experienced at least 2 VOCs within the 12 months prior to Screening.
A VOC is defined as:
a. The occurrence of appropriate symptoms consistent with a painful crisis, acute
chest syndrome (ACS), or priapism, and
b. Requires a visit to a medical facility and/or healthcare professional, and
c. Receipt of either a parenteral or oral opioid or NSAID analgesia.
5.If subject is receiving hydroxyurea (HU)/hydroxycarbamide (HC), subject must have been
receiving the treatment for at least 6 months prior to Screening and must agree to maintain the same dose and schedule for the duration of the study.
6.Subjects must have laboratory values at Screening within the following ranges:
Absolute Neutrophil Count =1.0 x 109/L
Platelets = 75 x 109/L
Hemoglobin (Hgb) = 6.0 g/dL
Glomerular filtration rate (GFR) = 45 mL/min/1.73 m2 using the CKD-EPI formula
Direct (conjugated) bilirubin = 2.0 x ULN
Alanine transaminase (ALT) = 3.0 x ULN
International Normalized Ratio (INR) = 2.0
7.Eastern Cooperate Oncology Group (ECOG) performance status = 2.
8.Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant, must have a negative serum pregnancy test at Screening and agree to
use standard prevention methods for the duration of the study.

Exclusion Criteria

1.Subject is receiving concomitant treatment with voxelotor, crizanlizumab, or L-glutamine.
2.Subject has any history of stem cell transplant is planning to begin or has received in the
past 30 days.
3.Subject experiences an acute VOC, requiring a visit to a medical facility and/or healthcare
professional, ending within 7 days prior to Day 1 dosing.
4.Subject has received any blood products within 30 days of Day 1 dosing.
5.Subject has uncontrolled liver disease or renal impairment, ulcerative colitis, Crohn’s
disease, or other chronic GI disorder.
6.Subject has received active treatment in another investigational trial within 30 days or 5
half-lives of the last dose of the investigational agent, whichever is greater, prior to
Screening.
7.Subject has received penicillin prophylaxis or antibiotics for treatment of infection within
30 days or 5 half-lives of the treatment, whichever is greater, prior to Screening.
8.Subject has a significant medical condition that required hospitalization (other than for a
VOC) within 2 months prior to Screening.
9.Subject is planning on undergoing an exchange transfusion during the duration of the study
or has completed one within 4 weeks prior to Day 1 dosing.
10.Subject has a hypersensitivity to rifaximin, rifampin, rifamycin antimicrobial agents, or any components of rifaximin ER and DER.
11.Subject has used therapeutic anticoagulation (prophylactic doses are permitted) or
antiplatelet therapy (other than aspirin or NSAIDs) within 10 days prior to Day 1 dosing.
12.Subject is pregnant or a nursing woman.
13.Subject has a history of illicit drug use or abuse, either documented or in the opinion of the Investigator.
14.Subject is using any medication that is known to inhibit or induce CYP3A4, P-gp, or
OATP1B1/B3 (See Appendix 3) within 30 days or 5 half-lives, whichever is longer, prior
to Day 1 dosing, or in the opinion of the Investigator, may affect the evaluation of the study
product or place the subject at

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration;Adverse events

Secondary Outcome Measures

Name	Time	Method
Adverse events, Maximum Plasma concentration; Maximum Plasma concentration

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