A Single Ascending Dose Study of PCO371 in Healthy Volunteers

A Randomized, Double-blind, Single Ascending Oral Dose Study To Evaluate Safety, Tolerability And Pharmacokinetics Of PCO371 In Healthy Volunteers

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02475616

Enrollment

Registered

2015-06-19

Start date

2015-06-30

Completion date

2015-10-31

Last updated

2015-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

This is a single-center, placebo-controlled, randomized, double-blind, dose-escalation study to evaluate safety, tolerability, and PK of a single oral (PO) administration of PCO371 in healthy adult males. Caucasian and Japanese subjects will be randomized to receive either PCO371 or placebo.

Interventions

DRUGPCO371

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male volunteers aged 18 to 45 years. * Caucasian(BMI 18-30 mg/kg2) or first generation japanese(BMI 18-25kg/m2) * Able and willing to abide by the protocol

Exclusion criteria

* Evidence of any medical condition that could affect renal, hepatic, or cardiopulmonary functions.

Design outcomes

Primary

Measure	Time frame	Description
Urine concentrations and PK parameters (cumulative excretion and renal clearance) of PCO371	15days or 22days	—
Safety as assessed by Laboratory test values	15days or 22days	Laboratory tests include hematology, biochemistry, urine analysis and coagulation
Safety as assessed by ECGs	15days or 22days	—
Plasma concentrations and PK parameters (AUC, Cmax, Tmax, total clearance, volume of distribution and T1/2) of PCO371 in healthy male volunteers	15days or 22days	—
Safety as assessed by adverse events	15days or 22days	—
Safety as assessed by temperature	15days or 22days	—
Safety as assessed by systolic blood pressure, diastolic blood pressure	15days or 22days	—
Safety as assessed by pulse rate	15days or 22days	—
Safety assessed by physical findings examinations, including weight	15days or 22days	—

Secondary

Measure	Time frame
The Urinary excretion of Ca, phosphate, magnesium, protein, sodium, potassium, chloride, and cAMP of PCO371	15days
The Nephrogenous cAMP of PCO371	15days
The Time profile of serum/plasma concentrations in albumin-corrected total calcium (Ca); 25-hydroxy vitamin D (vit D), 1,25-dihydroxy vit D, and 24,25-dihydroxy vit D; phosphate; magnesium; and cAMP of PCO371	15days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026