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A Study of PTC923 in Participants With Phenylketonuria

NCT05099640 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2024-01-10

Study results available
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Summary

The main purpose of this trial is to evaluate the efficacy of PTC923 in reducing blood phenylalanine (Phe) levels in participants with phenylketonuria as measured by mean change in blood Phe levels from baseline to Weeks 5 and 6 (that is, the average of each respective treatment dose 2-week period of double-blind treatment).

Conditions

Interventions

DRUG

PTC923

PTC923 powder for oral use will be suspended in water or apple juice prior to administration.

DRUG

Placebo

Placebo matching to PTC923

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2023-04-03
Completion
2023-05-03
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • Denmark
  • France
  • Georgia
  • Germany
  • Italy
  • Mexico
  • Netherlands
  • Portugal
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05099640 on ClinicalTrials.gov