Computational Modeling of Individual Metabolic PathwaysB2026N1NCT07462234
Continuous N-of-1 Computational Feasibility Study of a Whole Genome Sequence
An observational study of Computational Modeling of Individual Metabolic Pathways, run by Bioactify LLC at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Computational Modeling of Individual Metabolic Pathways
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2026to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Single adult participant providing previously collected Whole Genome Sequencing (WGS) data for observational, computational analysis. No recruitment or enrollment of additional participants.
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Automated Hypothesis Generation Via Deterministic Bioenergetic Simulation of a Whole Genome Sequence: A Continuous N-of-1 Computational Feasibility Study
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.
Read the detailed description
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.
- Keywords
- Whole Genome Sequencing, N-of-1, Computational Modeling, Metabolic Pathways, Flux Balance Analysis, Bioenergetics, Genomic Simulation, Deterministic Modeling, Secondary Data Analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single Participant | This cohort includes the single adult participant whose previously collected Whole Genome Sequencing (WGS) data will be used for computational analysis. No interventions, treatments, or clinical procedures are performed. All analyses are observational and based solely on secondary data. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Deterministic In Silico Metabolic Flux Simulation
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.
Measured: 3 months
Secondary outcomes (1)
Generation of a Jacobian Sensitivity Atlas
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start5 Mar 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Computational Modeling of Individual Metabolic PathwaysStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioactify LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Esther Cashbaugh, Principal investigator, Bioactify LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462234
- Sponsor's protocol ID
- B-2026-N1
- Acronym
- B2026N1
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study includes a single participant and uses previously collected Whole Genome Sequencing (WGS) data that cannot be de-identified.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Hypothesis Generation Via Deterministic Bioenergetic Simulation of a Whole Genome Sequence: A Continuous N-of-1 Computational Feasibility Study
- ClinicalTrials.gov ID
- NCT07462234
- Acronym / sponsor ID
- B2026N1 / B-2026-N1
- Keywords
- Whole Genome Sequencing, N-of-1, Computational Modeling, Metabolic Pathways, Flux Balance Analysis, Bioenergetics, Genomic Simulation, Deterministic Modeling
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Bioactify LLCUniversity, hospital or other
- Study start
- 5 Mar 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Participant | – | –This cohort includes the single adult participant whose previously collected Whole Genome Sequencing (WGS) data will be used for computational analysis. No interventions, treatments, or clinical procedures are performed. All analyses are observational and based solely on secondary data. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Single adult participant providing previously collected Whole Genome Sequencing (WGS) data for observational, computational analysis. No recruitment or enrollment of additional participants.
Key inclusion criteria (4 listed)
- Adult female participant, age 45
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Generation of a Jacobian Sensitivity Atlas
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study includes a single participant and uses previously collected Whole Genome Sequencing (WGS) data that cannot be de-identified.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esther Cashbaugh principal investigator
Bioactify LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Computational Modeling of Individual Metabolic Pathways, run by Bioactify LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Deterministic In Silico Metabolic Flux Simulation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.