Completed PHASE1 INTERVENTIONAL 2-arm NCT02750332

Bioavailability Food-Effect Study of an Oral Nitisinone Formulation to Treat Hereditary Tyrosinemia (HT-1)

A Single Center, Single-Dose, Open-Label, Randomized Study to Compare the Bioavailability of an Oral Test Formulation Containing Nitisinone 10 mg in at Least 16 Healthy Male and Female Subjects Under Fasting and Fed Conditions

Sponsor: Cycle Pharmaceuticals Ltd.

Conditions Hereditary Tyrosinemia, Type I

Interventions Nitisinone

Updated 6 times since 2017 Last updated: Feb 6, 2017 Started: Nov 30, 2015 Primary completion: Dec 31, 2015 Completion: Jan 31, 2016

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1 clinical study on Hereditary Tyrosinemia, Type I, this trial is completed. The trial is conducted by Cycle Pharmaceuticals Ltd. and has accumulated 6 data snapshots since 2015. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

6 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Jun 2018 — Jan 2021 [monthly]

Completed PHASE1
Feb 2017 — Jun 2018 [monthly]

Completed PHASE1

▶ Show 1 earlier version

Jan 2017 — Feb 2017 [monthly]

Completed PHASE1

First recorded

Nov 2015

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Cycle Pharmaceuticals Ltd.
Parexel

Data source: Cycle Pharmaceuticals Ltd.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Bloemfontein, South Africa