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What participation involves

NDI-5001 · Updated Oct 14, 2026 · IRB-approved Clinical Trial Worksheet of 14 Jul 2026

IRB-approved. Clinical Trial Worksheet, 14 Jul 2026. The text below is word for word from the approved sheet, except the trial number: the sheet prints NCT05190744, corrected here to NCT07525960.
CLINICAL TRIAL WORKSHEET

A Study in Adult Males With X-Linked Congenital Nephrogenic Diabetes Insipidus

There is a study testing an investigational drug, NDI-5001, in adult males with X-linked congenital nephrogenic diabetes insipidus (NDI) caused by vasopressin receptor type 2 (V2R/AVPR2) mutations.

ABOUT THIS STUDY

The purpose of this study is to learn more about the safety of NDI-5001, how it works in the body, and how well the body absorbs it.

WHO MAY PARTICIPATE

  • Males
  • 18 to 55 years of age
  • Have X-linked congenital nephrogenic diabetes insipidus

WHERE WILL THE STUDY TAKE PLACE?

Study locations will be discussed, and the site closest to you may be offered.

WHAT PARTICIPATION INVOLVES: STUDY TIMELINE

  1. 1
    ELIGIBILITY SCREENING

    Tests and check-ups will be done to determine if you may be eligible.

  2. 2
    CHECK-IN (DAY -4)Day -4

    Check-in to the study site for final checks before treatment begins. Remain onsite through the end of treatment

  3. 3
    IN-CLINIC TREATMENT & ASSESSMENT (Day -4 to Day 10)14 days
    • Stay at the clinical research unit for 14 days (including day -4).
    • Take NDI-5001 18 mg once daily for 9 days (Days 1-9).
    • Safety assessments and lab tests throughout your stay.
  4. 4
    FOLLOW-UP VISITS3 days
    • Day 17: Clinic visit or home health (home health available if used at screening)
    • Day 24: Phone call
    • Day 31: Clinic visit or home health (home health available if used at screening)
  5. 5
    FINAL SAFETY FOLLOW-UP1 day (Day 39)

    Phone call for safety follow-up about 30 days after the last study dose.

YOU MAY BE ELIGIBLE IF YOU:

  • Have X-linked NDI with a confirmed AVPR2 gene mutation and no mutation in AQP2.
  • Have very dilute urine (urine osmolality ≤ 200 mOsm/kg) in a first morning urine sample before eating or drinking.
  • Have an average weight (BMI) between 18.0 and 32.0 kg/m².

YOU MAY NOT BE ELIGIBLE IF YOU:

  • Are not willing to follow a low-sodium diet throughout the study.
  • Have a positive drug screen.
  • Have eGFR < 60 mL/min/1.73 m².
  • Have taken other investigational drugs within 30 days of starting this study.
  • Have previously taken NDI-5001.
  • Have a history of bleeding issues or hemorrhaging.

CLINICAL TRIAL REFERENCE

ClinicalTrials.gov Identifier: NCT07525960

Flourish Cited - Non-IRB
For NDIF calls only. This is our summary of the site's email answers, not IRB-approved material. Use it to answer questions on calls; don't send it to families or quote compensation as final. The IRB-approved worksheet above is the official version; where the two differ, follow it.

The participant's path

  1. 1ScreeningRemote; a home health nurse collects samples at home; window up to about 56 days
  2. 2Two-week stayIn the clinic; private room, meals provided
  3. 3Follow-upDay 17 clinic or home health; Day 24 phone call; Day 31 clinic or home health
  4. 4Final check-inDay 39, by phone; no visit

Screening

Can now be done remotely: a home health nurse arranged by the study sponsor collects samples at home, with no travel to a study center. The window can run up to about 56 days if that much time is needed. No repeat screening unless a result has to be redone.

The two-week stay

Participants stay in the clinic for 2 weeks, each in a private room, with meals provided. After discharge they go home.

After the stay

Day 17: clinic visit or home health. Day 24: phone call. Day 31: clinic visit or home health. Home health is available if it was used at screening. Visits aren't overnight stays; the site said each takes about 30 minutes to an hour. Day 39 is a phone call, not a visit.

Travel

A third-party travel concierge books and pays for travel to every visit. People coming from farther away are generally flown in and put in a hotel the night before a visit.

The concierge's contact details go to participants once they decide to take part and the site emails the service. The concierge has a phone app for travel and for submitting receipts for incidentals.

Family and companions

Companion travel is allowed. The clinic has 2 private rooms with queen-size beds for participants who need a family member to stay. Specifics, such as a companion's travel costs, are handled case by case with the concierge.

Compensation

About $15,000–$16,000 in total, paid onto a card the site loads with money. The site can pay in stages or all at the end. Not IRB-approved wording yet.

Still to confirm

  • IRB-approved wording for compensation (the 14 Jul 2026 worksheet doesn't cover it)
  • Whether someone who withdraws or is discontinued partway is paid for the part completed
  • Whether a companion's travel and lodging are covered
  • Whether the San Antonio site runs the same schedule

Source: email from Sonia Gerardo, RN, CCRC, Site Manager, Encore Research Group (Flourish Research), Jacksonville, Jul 31, 2026. Remote screening: NDIF emails to families, Oct 9, 2026.

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