Peptide Library

Human study PLS-00218

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

Other design · 30 participants enrolled

Version 1 · published November 8, 2026 · evidence through November 8, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

Reports of this study

Every publication, registration and abstract describing this one study. Participants are counted once.

  • A Phase 1 Study Examining the Pharmacokinetics and Tolerability of a Single Oral Dose of Bendavia (MTP-131)registry entry · NCT01754818 (COMPLETED, no results posted, planned enrollment 30)

Design and participants

Design
Other design
Population
Healthy volunteers
Conditions
Healthy
Planned enrollment (registry)
30
Enrolled
30
Randomized
Not reported
Completed follow-up
Not reported

Intervention and comparator

What each group received. Related peptides, analogs and combinations are never treated as the compound itself.

  • Bendavia dose level 1 (intervention) · elamipretide · Bendavia (MTP-131, elamipretide), single oral dose, lowest of three registered dose levels · oral · single dose · Not reported assigned
  • Bendavia dose level 2 (intervention) · elamipretide · Bendavia (MTP-131, elamipretide), single oral dose, middle of three registered dose levels · oral · single dose · Not reported assigned
  • Bendavia dose level 3 (intervention) · elamipretide · Bendavia (MTP-131, elamipretide), single oral dose, highest of three registered dose levels · oral · single dose · Not reported assigned
  • Placebo (comparator) · Placebo · placebo · oral · single dose · Not reported assigned

What the authors reported

As stated in the sources. This is the authors’ account, not Peptide Library’s assessment.

Pharmacokinetics after a single oral dose

unclear outcome · surrogate · Not stated beyond the study title

  • No results reported.

Tolerability after a single oral dose

unclear outcome · safety · Not stated beyond the study title

  • No results reported.

Adverse events

None reported. That is not evidence of safety.

Monitoring: Tolerability is named in the title as a study aim. No monitoring procedures are described in the record.

The authors concluded (paraphrased): No conclusions are available. The registry record has no posted results and no publication.

Peptide Library’s assessment

An automated assessment, made by AI separately from the authors’ conclusions and not reviewed by a person. How risk of bias is assessed.

Limitations

  • other: The record is a registry entry only, with has_results false and no publication, so no outcome data are available.
  • selective reporting: The study is listed as completed but no results have been posted, which raises the possibility of non-reporting.
  • inappropriate population: Healthy volunteers were enrolled, not patients with Barth syndrome or mitochondrial myopathy.
  • short follow up: A single oral dose was given, so the study cannot inform repeated-dose safety or efficacy.
  • small or imprecise: Only 30 participants were enrolled across three dose groups and a placebo group.
  • inappropriate endpoint: The study aims at pharmacokinetics and tolerability and measured no clinical efficacy outcomes.

No risk-of-bias assessment has been published for this study’s results.

Claims this study informs

Where each value comes from

  • arms: NCT NCT01754818, registry (interventions field) · extracted by AI (automated, not verified by a person)
  • design: NCT NCT01754818, registry (phases and study_type fields) · extracted by AI (automated, not verified by a person)
  • limitations: NCT NCT01754818, registry (has_results and status fields) · extracted by AI (automated, not verified by a person)
  • outcomes: NCT NCT01754818, title (study title) · extracted by AI (automated, not verified by a person)
  • participants: NCT NCT01754818, registry (enrollment and enrollment_type fields) · extracted by AI (automated, not verified by a person)
  • population: NCT NCT01754818, registry (conditions field) · extracted by AI (automated, not verified by a person)

  • Version 1 · published November 8, 2026 · evidence through November 8, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

These assessments describe published research. Records marked automated were produced by AI under the published methodology and have not been reviewed by a person; they can contain errors. None of this is medical advice, not a statement about any product’s safety for human use, and not a regulatory approval. Peptide Library’s vendor and partner relationships play no part in them (editorial independence).