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NCT03708146
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIA 5-1058
Phase 1 trial testing BIA 5-1058 in Cardiovascular Disease+Pulmonary Disease in 157 participants. Completed in 18 March 2019.
18 March 2019
Quick facts
| Lead sponsor | Bial - Portela C S.A. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 157 |
| Start date | 28 May 2018 |
| Primary completion | 18 March 2019 |
| Estimated completion | 18 March 2019 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- BIA 5-1058 — full drug profile →
- Placebo
Conditions studied
- Cardiovascular Disease+Pulmonary Disease — all drugs for Cardiovascular Disease+Pulmonary Disease →
- Pulmonary Arterial Hypertension — all drugs for Pulmonary Arterial Hypertension →
Sponsor
Bial - Portela C S.A. — full company profile →
Who can join
Adults 18 to 55, any sex, with Cardiovascular Disease+Pulmonary Disease or Pulmonary Arterial Hypertension. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a single centre, double-blind, randomised, placebo-controlled, parallel staggered group study of BIA 5-1058 in 11 different cohorts of 15 healthy subjects. Subjects will be randomly assigned to receive once-daily oral doses of BIA 5-1058 or matching placebo for 10 days. The primary objectives of the study are to assess the safety and tolerability of BIA 5-1058 after repeated ascending doses under fed and fasted conditions and to assess the pharmacokinetics (PK) of BIA 5-1058 after repeated ascending doses under fed conditions having matching fasting cohorts for comparison of bioavailability. It is planned that comparison cohorts will be dosed in parallel, i.e. Cohorts 1 and 2, 3 and 4, 5 and 6, 7 and 8 and 9 and 10. Cohorts may be split or dosed sequentially for logistical purposes; however, data from both comparison cohorts (e.g. Cohorts 1 and 2) must be available before dose escalation to the next dose levels.
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:
- PubMed search for NCT03708146
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT04994860 — Effect of BIA 5-1058 400 mg on the Steady State Pharmacokinetics of Sildenafil · Phase 1 · completed
- NCT04675944 — Effect of BIA 5-1058 on the Steady State Pharmacokinetics of Treprostinil · Phase 1 · completed
- NCT04994119 — Effect of BIA 5-1058 400 mg on Warfarin Pharmacokinetics · Phase 1 · completed
Other Bial - Portela C S.A. trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03708146 (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: 31 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/NCT03708146.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing