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NCT Number: NCT07462234

Continuous N-of-1 Computational Feasibility Study of a Whole Genome Sequence

This is an observational, computational N-of-1 study that uses previously collected Whole Genome Sequencing (WGS) data from a single adult participant to evaluate the feasibility of a deterministic bioenergetic simulation model. The study does not involve clinical interventions, treatments, or prospective specimen collection. All analyses are performed on existing genomic data in a secure computational environment.

The purpose of this study is to determine whether a physics-based metabolic model can successfully integrate individual genomic constraints to generate personalized, hypothesis-driven insights about metabolic pathways. The study focuses on model feasibility and computational performance, not clinical outcomes. No medications, diets, or behavioral interventions are administered or evaluated.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Computational Modeling of Individual Metabolic Pathways

Sex eligibility

Female

Study type

Observational

Primary location

Bioactify LLC

Wappingers Falls, New York, 12590, United States

About this study

This protocol (B-2026-N1) describes a continuous, observational N-of-1 computational feasibility study conducted by Bioactify LLC and What Ifs Tech Inc. The study uses secondary, commercially obtained 30x Whole Genome Sequencing (WGS) data from a single adult participant. No new data are collected for research purposes, and no clinical interventions are performed.

The primary objective is to assess the feasibility of integrating static genomic constraints into a deterministic simulation engine that incorporates Flux Balance Analysis (FBA) and dynamic physiologically based modeling. The computational framework is designed to explore how individual genetic variants may influence metabolic pathway behavior. All analyses occur within an isolated cloud environment using pre-existing data.

This study is observational and exploratory. It does not evaluate the safety, efficacy, or clinical utility of any treatment, diet, medication, or device. The research aims to generate methodological insights about individualized computational modeling and hypothesis generation.

This study received an Exempt Research Determination from Pearl IRB (Protocol ID: 2026-0119) under 45 CFR 46.104(d)(4), as it involves only secondary use of existing data with no interaction or intervention with human subjects.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult female participant, age 45
  • Possesses previously collected 30x Whole Genome Sequencing (WGS) data
  • Able to provide self-reported phenotypic and lifestyle information as needed for computational analysis
  • Willing to participate in a self-directed, observational N-of-1 study

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Feasibility of Deterministic In Silico Metabolic Flux Simulation

    Time frame: 3 months

    Assesses whether secondary 30x Whole Genome Sequencing (WGS) data can be successfully ingested and processed by a deterministic computational framework that incorporates Flux Balance Analysis (FBA) and dynamic physiologically based modeling. Feasibility is defined by the ability to run simulations without system failure, data corruption, or computational instability. This outcome evaluates computational performance only and does not assess clinical endpoints.

Secondary outcomes

  1. Generation of a Jacobian Sensitivity Atlas

    Time frame: 3 months

    Evaluates whether the simulation engine can successfully generate a differentiable sensitivity atlas that identifies potential enzymatic or transport constraints based solely on static genomic inputs. This outcome assesses algorithmic output quality and computational stability, not clinical or diagnostic interpretation.

Sponsors and collaborators

Lead sponsor

Bioactify LLC

Other

Registry information

Official study title

Automated Hypothesis Generation Via Deterministic Bioenergetic Simulation of a Whole Genome Sequence: A Continuous N-of-1 Computational Feasibility Study

Acronym: B2026N1

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 10, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.