NCT04675944 is a Phase 1 clinical trial of BIA 5-1058 in Pulmonary Arterial Hypertension, sponsored by Bial - Portela C S.A..

Who is sponsoring NCT04675944?

NCT04675944 is sponsored by Bial - Portela C S.A..

What drugs are being tested in NCT04675944?

Interventions in NCT04675944: BIA 5-1058, treprostinil.

What condition does NCT04675944 study?

NCT04675944 studies Pulmonary Arterial Hypertension.

Is NCT04675944 still recruiting?

NCT04675944 is currently completed. Last updated 19 December 2020.

Last reviewed 2020-12-19 · How we verify

NCT04675944

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Effect of BIA 5-1058 on the Steady State Pharmacokinetics of Treprostinil

Completed Phase 1 Last updated 19 December 2020

What this trial tests

Phase 1 trial testing BIA 5-1058 in Pulmonary Arterial Hypertension in 20 participants. Completed in 25 May 2018.

Timeline

28 February 2018

Primary endpoint
25 May 2018

25 May 2018

Quick facts

Lead sponsor	Bial - Portela C S.A.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	28 February 2018
Primary completion	25 May 2018
Estimated completion	25 May 2018
Sites	1 location across Germany

Drugs / interventions tested

BIA 5-1058 — full drug profile →
treprostinil (TREPROSTINIL) — full drug profile →

Conditions studied

Pulmonary Arterial Hypertension — all drugs for Pulmonary Arterial Hypertension →

Sponsor

Bial - Portela C S.A. — full company profile →

Who can join

Adults 18 to 45, any sex, with Pulmonary Arterial Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to assess the effect of BIA 5-1058 200 mg on the pharmacokinetic (PK) of treprostinil

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of BIA 5-1058

Trials testing the same drug.

NCT07173738 — Pharmacokinetics, Safety and Tolerability of Concurrent Doses of BIA 5-1058 and Furosemide · Phase 1 · completed
NCT03708146 — Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIA 5-1058 · Phase 1 · completed
NCT03489005 — Effect of BIA 5 1058 on Cardiac Repolarization · Phase 1 · completed
NCT04994860 — Effect of BIA 5-1058 400 mg on the Steady State Pharmacokinetics of Sildenafil · Phase 1 · completed
NCT04994119 — Effect of BIA 5-1058 400 mg on Warfarin Pharmacokinetics · Phase 1 · completed

Other recruiting trials for Pulmonary Arterial Hypertension

Currently open trials in the same condition.

NCT07391228 — Cognitive Alterations in Pulmonary Arterial Hypertension (PAH) · active not recruiting
NCT06351345 — 129 Xenon Imaging in Patients Treated With Sotatercept · Phase 2 · recruiting
NCT07217522 — Rutgers University Study of the Genetics of Pulmonary Hypertension · recruiting
NCT07013149 — The Impact of ERA Switching on Risk Stratification in Pulmonary Arterial Hypertension · recruiting
NCT06658522 — Right Ventricular Compensation With Sotatercept: A Prospective Single Arm Open Label Phase 4 Study to Evaluate the Effec · Phase 4 · recruiting

Other Bial - Portela C S.A. trials

Trials by the same sponsor.

NCT07403799 — REal-life ON PARKinson's - ITaly (REONPARK-IT) · recruiting
NCT04990284 — eArly levoDopa With Opicapone in Parkinson's paTients wIth motOr fluctuatioNs. · Phase 4 · completed
NCT04986995 — OpicApone Sleep dISorder · Phase 4 · completed
NCT04978597 — Early ParkinSon wIth L-DOPA/DDCI and OpicapoNe (EPSILON Study) · Phase 3 · completed
NCT04986982 — OpiCapone Effect on Motor Fluctuations and pAiN · Phase 4 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04675944 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bial - Portela C S.A.
Last refreshed: 19 December 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04675944.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing