Is NCT07713758 recruiting in Miami, FL?

Yes, NCT07713758 is currently recruiting participants at its Miami, FL location. This phenylketonuria clinical trial is actively enrolling qualified participants.

How do I join the phenylketonuria clinical trial in Miami?

To join this clinical trial in Miami, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Miami clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Phenylketonuria Clinical Trial in Miami, FL

About This Phenylketonuria Study in Miami

This trial is intended to understand how the body processes repinatrabit in people with moderate liver impairment and severe kidney impairment and also to compare these results with people of similar age, weight, and sex who have normal liver function.

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Who Can Participate

Inclusion Criteria

Body mass index (BMI) from 18.0 to 38.0 kilograms per square meter (kg/m\^2) (inclusive).

Able to provide written, informed consent.

Male participants and female participants of childbearing potential (POCBP) must agree to remain fully abstinent from intercourse where pregnancy can occur OR practice 2 different contraceptive methods, where at least one must be highly effective.

Otherwise be in generally good health.

Additional criteria for Group 1: i. Have moderate hepatic impairment determined using Child-Pugh classification (Class B). ii. Have relatively stable hepatic function for the duration of the study as determined by the investigator and liver function test at the time of screening or stable hepatic function 1 year prior to screening. iii. Have normal renal function. iv. Have a clinical diagnosis of hepatic cirrhosis based on biopsy and/or clinical criteria.

Additional criteria for Group 2: i. Have estimated glomerular filtration rate based on the Chronic Kidney Disease-Epidemiology Collaboration (eGFRCKD-EPI) lesser than (\<) 30 milliliters per minute per 1.73 square meters (mL/min/1.73 m\^2) indicating severe renal impairment. ii. Not currently be on dialysis. iii. Have relatively stable renal function as determined by eGFRCKD-EPI. 7) Additional criteria for Group 3: i. eGFRCKD-EPI greater than or equal to (≥) 90 mL/min/1.73 m\^2 indicating normal renal function. ii. Have liver enzymes within normal limits.

Exclusion Criteria

Participants who are breastfeeding.

Participants who have a positive pregnancy test result prior to receiving the investigational medical product (IMP).

Participants with international normalized ratio (INR) greater than (\>) 2.3. Participants with hepatic impairment with elevated INR will be excluded based on the investigator's discretion.

Participants with hepatic carcinoma or porto-hepatic shunts that have been surgically created or planted.

A history of difficulty in obtaining intravenous access.

The donation of blood or plasma \> 250 milliliters (mL) within 30 days prior to screening or received \> 50 mL of blood or plasma within 30 days prior to screening.

Participants who have taken an investigational drug within 30 days prior to screening.

Exposure to any substances known to stimulate hepatic microsomal enzymes within 30 days prior to screening (eg, occupational exposure to pesticides, organic solvents, etc).

Any participant who, in the opinion of the investigator, should not participate in the trial.

Previous exposure to repinatrabit.

Additional criteria for Group 1: History of serious mental disorder including participants who have greater than Grade 1 encephalopathy as assessed by the Child-Pugh score and/or the investigator's judgment.

Additional criteria for Group 2: i) Participants that have undergone a renal transplant. ii) Participants expected to require dialysis within 45 days. iii) Clinically significant abnormal findings in the serum chemistry, hematology, or urinalysis results obtained at screening or on Day -1, other than those associated with underlying renal conditions and other stable medical conditions consistent with the disease processes.

Additional criteria for Group 3: History of or current hepatitis, or carriers of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibodies (anti-HC). Note: Other protocol-specified inclusion/exclusion criteria may apply.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Miami?

Yes, this clinical trial (NCT07713758) has an active research site in Miami, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Phenylketonuria Treatment Options in Miami, FL

If you're searching for phenylketonuria treatment options in Miami, FL, this clinical trial (NCT07713758) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Miami research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced phenylketonuria specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all phenylketonuria clinical trials near you to find additional studies recruiting in your area.

Phenylketonuria Clinical Trial in Miami, FL

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