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NCT01520987 · ClinicalTrials.gov registry record · Phase 1

Pharmacokinetics of BIA 9-1067 in Healthy Japanese and Caucasian Subjects

A Phase 1 study, sponsored by Bial - Portela C S.A..

Completed
Registry status
Phase 1
Development phase
105
Enrollment target

NCT01520987: Completed Phase 1 study, sponsored by Bial - Portela C S.A..

NCT01520987 is a Phase 1 study that has completed, run by Bial - Portela C S.A.. The registered enrollment target is 105 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01520987, a Phase 1 study, has completed, sponsored by Bial - Portela C S.A..

COMPLETED
Registry status
Phase 1
Development phase
105 participants
Enrollment target

Study Summary

To assess the pharmacokinetics of BIA 9-1067 in healthy Japanese subjects

Primary Outcome

Cmax - maximum observed plasma concentration following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose.

Interventions

  • DRUG Placebo
  • DRUG BIA 9-1067

Trial Details

FieldValue
Enrollment Target 105 participants
Start Date 2011-05
Est. Completion 2012-11
Phase Phase 1
Bial - Portela C S.A.

4 total trials

What the finished NCT01520987 record still lists

NCT01520987 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01520987 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01520987 about?

NCT01520987 is a clinical study titled "Pharmacokinetics of BIA 9-1067 in Healthy Japanese and Caucasian Subjects". To assess the pharmacokinetics of BIA 9-1067 in healthy Japanese subjects

What is the current status of trial NCT01520987?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 105 participants. The study started on 2011-05. Estimated completion is 2012-11.

What interventions are being tested in trial NCT01520987?

The interventions under investigation include: Placebo (DRUG), BIA 9-1067 (DRUG).

Who is sponsoring clinical trial NCT01520987?

This trial is sponsored by Bial - Portela C S.A., which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01520987's enrollment target sits among peer trials

105 533rd of 2000 higher than 1,465 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01520987, the US trial registry maintained by the National Library of Medicine. NCT01520987 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.