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COMPLETED Phase 1

A Phase 1 Study Examining the Pharmacokinetics and Tolerability of a Single Oral Dose of Bendavia (MTP-131)

NCT01754818 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to assess the study medication blood levels after administration of a single oral capsule of Bendavia at one of three dose levels. The effects of Bendavia on the volunteers will also be assessed.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Bendavia 10mg
  • DRUG Bendavia 50mg
  • DRUG Bendavia 100mg

Study Locations (1)

Florida

  • Clinical Pharmacology of Miami — Miami

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2012-11
Est. Completion 2013-02
Phase Phase 1

Sponsor

Stealth BioTherapeutics

8 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01754818

The ClinicalTrials.gov registry entry for NCT01754818 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stealth BioTherapeutics, which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 4 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01754818 reports 1 study location spanning 1 distinct geographic area — top geographies include Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01754818 about?

NCT01754818 is a clinical study titled "A Phase 1 Study Examining the Pharmacokinetics and Tolerability of a Single Oral Dose of Bendavia (MTP-131)". The purpose of this study is to assess the study medication blood levels after administration of a single oral capsule of Bendavia at one of three dose levels. The effects of Bendavia on the volunteers will also be assessed.

What is the current status of trial NCT01754818?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2012-11. Estimated completion is 2013-02.

What conditions does trial NCT01754818 study?

This clinical trial studies the following conditions: Healthy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01754818?

The interventions under investigation include: Placebo (DRUG), Bendavia 10mg (DRUG), Bendavia 50mg (DRUG), Bendavia 100mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01754818?

This trial is sponsored by Stealth BioTherapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01754818 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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