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NCT02829541 · ClinicalTrials.gov registry record · Phase 1

A Phase 1, Single-Ascending-Dose, Safety, Tolerability, Pharmacokinetic(PK), and Pharmacodynamic(PD) Study of BIIB068 in Healthy Participants

A Phase 1 study, sponsored by Biogen.

Completed
Registry status
Phase 1
Development phase
36
Enrollment target

NCT02829541 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 36 participants.

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The verdict

NCT02829541, a Phase 1 study, has completed, sponsored by Biogen.

COMPLETED
Registry status
Phase 1
Development phase
36 participants
Enrollment target

Study Summary

The primary objective of the study is to evaluate the safety and tolerability of single oral doses of BIIB068 in healthy participants. Secondary objectives are to characterize the single-oral-dose Pharmacokinetic (PK) of BIIB068 in healthy participants, to determine the effect of food on the single-oral-dose PK of BIIB068 in healthy participants and to examine the effect of administration of the proton pump inhibitor (PPI) esomeprazole on the single-dose PK of BIIB068 in healthy participants.

Interventions

  • DRUG Placebo
  • DRUG BIIB068

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2016-08
Est. Completion 2016-12
Phase Phase 1

Sponsor

Biogen

334 total trials

What the Registry Record Tells You About NCT02829541

The ClinicalTrials.gov registry entry for NCT02829541 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.

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

NCT02829541 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02829541 about?

NCT02829541 is a clinical study titled "A Phase 1, Single-Ascending-Dose, Safety, Tolerability, Pharmacokinetic(PK), and Pharmacodynamic(PD) Study of BIIB068 in Healthy Participants". The primary objective of the study is to evaluate the safety and tolerability of single oral doses of BIIB068 in healthy participants. Secondary objectives are to characterize the single-oral-dose Pharmacokinetic (PK) of BIIB068 in healthy participants, to determine the effect of food on the single-...

What is the current status of trial NCT02829541?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2016-08. Estimated completion is 2016-12.

What interventions are being tested in trial NCT02829541?

The interventions under investigation include: Placebo (DRUG), BIIB068 (DRUG).

Who is sponsoring clinical trial NCT02829541?

This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.