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A Study in Adult Males With X-linked Congenital Nephrogenic Diabetes Insipidus to Test the Effects of NDI-5001 Given for Multiple Days and to Test How NDI-5001 is Tolerated and Taken up in the Body

Otsuka Pharmaceutical Development & Commercialization, Inc. · NCT07525960

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–55 · Men only
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1
Target enrollment
24
US sites recruiting
2
Study start
July 7, 2026
Record last updated
October 20, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

The primary purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NDI-5001 administered as a capsule following daily oral dosing in adult males with X-linked congenital nephrogenic diabetes insipidus (NDI) due to vasopressin receptor Type 2 (V2R) mutations.

Being studied: NDI-5001

Conditions: Diabetes Insipidus

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • X-linked congenital NDI with a genotype-confirmed arginine vasopressin receptor 2 (gene) (AVPR2) mutation and no mutation in aquaporin-2 (AQP2).
  • Urine osmolality of ≤ 200 milliosmoles per kilogram of water (mOsm/kg) in a spot urine sample obtained from a first morning void upon awakening (at screening) before consuming any food or drink after awakening.
  • BMI between 18.0 to 35.0 kilograms per square meter (kg/m\^2), inclusive.

Exclusion Criteria

  • Participant who is not willing to follow a low-sodium (\<=1 gram/day) diet during the in-clinic portion of the trial.
  • A positive drug screen for substances of abuse (including THC, cannabidiol) at screening or check-in.
  • Estimated glomerular filtration rate \<60 milliliters per minute per 1.73-kilogram square meters by serum creatinine and cystatin C at screening.
  • Participants who have taken an investigational drug within 30 days prior to screening.
  • Previous exposure to NDI-5001.
  • Any history of significant bleeding or hemorrhagic tendencies.

Note: Other protocol-specified inclusion/exclusion criteria may apply.

Recruiting US locations

  • Flourish Jacksonville

    Jacksonville, FL 32277

    Site contact: Chebib · 844-687-8522 · Otsuka-ProfessionalServices@otsuka-us.com

  • Flourish San Antonio

    San Antonio, TX 78023

    Site contact: Denham · 844-687-8522 · Otsuka-ProfessionalServices@otsuka-us.com

Study contacts (from the official record)

  • Otsuka Call Center · 844-687-8522 · Otsuka-ProfessionalServices@otsuka-us.com
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A Study in Adult Males With X-linked Congenital Nephrogenic… (NCT07525960) | Bored Studies