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NCT01862939 · ClinicalTrials.gov registry record · Phase 1

A Two-Part, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DS-7309 in Healthy Volunteers and Subjects With Type 2 Diabetes Mellitus

A Phase 1 study, sponsored by Daiichi Sankyo.

Completed
Registry status
Phase 1
Development phase
52
Enrollment target

NCT01862939 is a Phase 1 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 52 participants.

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The verdict

NCT01862939, a Phase 1 study, has completed, sponsored by Daiichi Sankyo.

COMPLETED
Registry status
Phase 1
Development phase
52 participants
Enrollment target

Study Summary

This is a randomized, placebo-controlled, 2-part, sequential, single ascending dose study. Part 1 is planned as 6 sequential escalation treatment groups. Part 2 is a randomized, placebo-controlled, two-period sequential pharmacodynamic (PD) arm.

Interventions

  • DRUG placebo
  • DRUG DS-7309

Trial Details

FieldValue
Enrollment Target 52 participants
Start Date 2011-04
Est. Completion 2011-09
Phase Phase 1

Sponsor

Daiichi Sankyo

236 total trials

What the Registry Record Tells You About NCT01862939

The ClinicalTrials.gov registry entry for NCT01862939 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Daiichi Sankyo, which has 236 total studies on file at ClinicalTrials.gov.

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

NCT01862939 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01862939 about?

NCT01862939 is a clinical study titled "A Two-Part, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DS-7309 in Healthy Volunteers and Subjects With Type 2 Diabetes Mellitus". This is a randomized, placebo-controlled, 2-part, sequential, single ascending dose study. Part 1 is planned as 6 sequential escalation treatment groups. Part 2 is a randomized, placebo-controlled, two-period sequential pharmacodynamic (PD) arm.

What is the current status of trial NCT01862939?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2011-04. Estimated completion is 2011-09.

What interventions are being tested in trial NCT01862939?

The interventions under investigation include: placebo (DRUG), DS-7309 (DRUG).

Who is sponsoring clinical trial NCT01862939?

This trial is sponsored by Daiichi Sankyo, which has 236 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.