HealthyPhase 1NCT07839000
A Clinical Trial to Evaluate [14C]-MK-4208/[14C]-TERN-701 in Healthy Adult Male Participants (MK-4208-002/TERN701-1016)
A Phase 1 study testing TERN-701 in people with Healthy, run by Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 1 site in United States.
Trial summary
The goal of the study is to learn what happens to different forms of TERN-701 medications in a healthy person's body over time. Researchers will compare what happens to different forms of TERN-701 in a person's body over time. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- TERN-701
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2026to 3 Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The main inclusion criteria include but are not limited to the following:
- Has body mass index (BMI) ≥18.5 and ≤32.0 kg/m^2
- Is in good health
Who cannot join
- The main exclusion criteria include but are not limited to the following:
- Has history or presence of any medical condition or prior surgery that may impact typical absorption, distribution, metabolism, or excretion of the orally administered study drug (e.g., gastric bypass, gastrointestinal dysmotility, irritable or inflammatory bowel disease)
- Has history or laboratory evidence of hyperthyroidism (thyroid-stimulating hormone [TSH] < lower limit of normal [LLN]) or hypothyroidism (TSH ≥8 mIU/L)
- Has history of cancer that has not been in complete remission for > 5 years (except basal cell skin cancer or squamous cell skin cancer with a history of curative treatment and no recurrence for > 1 year prior)
- Has history of dysphagia, aspiration, or other conditions that could potentially impede the ability to safely orally ingest the study drug per protocol
- Has history of incomplete bladder emptying with voiding (i.e., urinary retention) or recent history of awakening more than once at night to void
Show all 9Show fewer
- Has usual habit of < 1 or > 3 bowel movements per day
- Has family history of long QT syndrome or of unexplained sudden death in a first-degree relative under 50 years of age
- Has documented congenital or acquired long QT syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Mass Balance Study to Investigate the Absorption, Distribution, Metabolism, and Excretion of 14C-TERN-701 Following Administration of a Single Oral Dose in Healthy Adult Male Participants
The goal of the study is to learn what happens to different forms of TERN-701 medications in a healthy person's body over time. Researchers will compare what happens to different forms of TERN-701 in a person's body over time.
The goal of the study is to learn:
- What happens to different forms of TERN-701 in a person's body over time.
- The amount and number of different forms of TERN-701 that leave a person's body over time.
- Conditions
- Healthy
- Being tested
- TERN-701
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TERN-701Drug
Also called MK-4208, HS-10382
Oral Liquid radiolabeled with [14C]-TERN-701
| Study group | Role | What they receive |
|---|---|---|
| [14C]-TERN-701 | Experimental | Participants receive a single oral dose of radiolabeled TERN-701 ([14C]-TERN-701) on Day 1. Receives: Drug: TERN-701 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Total Amount of [14C]-Radiolabel Excreted into Urine per Sampling Interval (Aeurine,14C,t1-t2)
Urine will be collected to determine the Aeurine,14C,t1-t2 of radiolabeled [14C]-TERN-701.
Measured: Pre-dose and at designated time points up to 408 hours post dose
Cumulative Percentage of Total Amount of [14C]-Radiolabel Excreted into Urine up to the Last Sampling Interval (Aeurine,14C)
Urine will be collected to determine the Aeurine,14C of radiolabeled [14C]-TERN-701.
Measured: Pre-dose and at designated time points up to 408 hours post dose
Percentage of Total Amount of [14C]-Radiolabel Excreted into Feces per Sampling Interval (Aefeces,14C,t1-t2)
Feces will be collected to determine the Aefeces,14C,t1-t2 of radiolabeled [14C]-TERN-701.
Measured: Pre-dose and at designated time points up to 408 hours post dose
Cumulative Percentage of Total Amount of [14C]-Radiolabel Excreted into Feces Up to the Last Sampling Interval (Aefeces,14C)
Feces will be collected to determine the Aefeces,14C of radiolabeled [14C]-TERN-701.
Measured: Pre-dose and at designated time points up to 408 hours post dose
Percentage of Total Amount of [14C]-Radiolabel Excreted from Body per Sampling Interval (Aetotal, 14C, t1-t2)
Urine and Feces will be collected to determine the Aetotal,14C,t1-t2 of radiolabeled [14C]-TERN-701.
Measured: Pre-dose and at designated time points up to 408 hours post dose
Cumulative Percentage of Total Excretion of [14C]-Radiolabel from the Body (Aetotal, 14C)
Urine and Feces will be collected to determine the Aetotal,14C of radiolabeled [14C]-TERN-701. Calculated as, Aetotal,14C= Aeurine,14C +Aefeces,14C.
Measured: Pre-dose and at designated time points up to 408 hours post dose
Maximum Concentration Observed in Plasma (Cmax) of TERN-701 in Plasma
Blood samples will be collected to determine the Cmax of TERN-701.
Measured: Pre-dose and at designated time points up to 408 hours post dose
Time to Maximum Concentration Observed in Plasma (Tmax) of TERN-701 in Plasma
Blood samples will be collected to determine the Tmax of TERN-701.
Measured: Pre-dose and at designated time points up to 408 hours post dose
Apparent Terminal Half-Life (t1/2) of TERN-701 in Plasma
Blood samples will be collected to determine the t1/2 of TERN-701.
Measured: Pre-dose and at designated time points up to 408 hours post dose
Area Under the Concentration-Time Curve from Time 0 to the Last Quantifiable Concentration (AUC0-last) of TERN-701 in Plasma
Blood samples will be collected to determine the AUC0-Last of TERN-701.
Measured: Pre-dose and at designated time points up to 408 hours post dose
Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-Inf) of TERN-701 in Plasma
Blood samples will be collected to determine the AUC0-inf of TERN-701.
Measured: Pre-dose and at designated time points up to 408 hours post dose
Apparent Oral Clearance (CL/F) of TERN-701 in Plasma
Blood samples will be collected to determine the CL/F of TERN-701.
Measured: Pre-dose and at designated time points up to 408 hours post dose
Apparent Volume of Distribution (Vz/F) of TERN-701 in Plasma
Blood samples will be collected to determine the Vz/F of TERN-701.
Measured: Pre-dose and at designated time points up to 408 hours post dose
Total [14C]-Radiolabel in Plasma
Blood samples will be collected to determine the Total [14C]-Radiolabel, calculated as the AUCinf of non-radiolabeled TERN-701 in plasma divided by the AUCinf of total [14C]-radiolabel in plasma.
Measured: Pre-dose and at designated time points up to 408 hours post dose
Tmax of Total [14C]-Radiolabel in Plasma
Blood samples will be collected to determine the Tmax of radiolabeled [14C]-TERN-701.
Measured: Pre-dose and at designated time points up to 408 hours post dose
t1/2 of Total [14C]-Radiolabel in Plasma
Blood samples will be collected to determine the t1/2 of radiolabeled [14C]-TERN-701.
Measured: Pre-dose and at designated time points up to 408 hours post dose
AUC0-last of Total [14C]-Radiolabel in Plasma
Blood samples will be collected to determine the AUC0-last of radiolabeled [14C]-TERN-701.
Measured: Pre-dose and at designated time points up to 408 hours post dose
AUC0-Inf of Total [14C]-Radiolabel in Plasma
Blood samples will be collected to determine the AUC0-Inf of radiolabeled [14C]-TERN-701.
Measured: Pre-dose and at designated time points up to 408 hours post dose
Cmax of Total [14C]-Radiolabel in Plasma
Blood samples will be collected to determine the Cmax of radiolabeled [14C]-TERN-701.
Measured: Pre-dose and at designated time points up to 408 hours post dose
Tmax of Total [14C]-Radiolabel in Whole Blood
Blood samples will be collected to determine the Tmax of radiolabeled [14C]-TERN-701.
Measured: Pre-dose and at designated time points up to 408 hours post dose
t1/2 of Total [14C]-Radiolabel in Whole Blood
Blood samples will be collected to determine the t1/2 of radiolabeled [14C]-TERN-701.
Measured: Pre-dose and at designated time points up to 408 hours post dose
AUC0-last of Total [14C]-Radiolabel in Whole Blood
Blood samples will be collected to determine the AUC0-last of radiolabeled [14C]-TERN-701.
Measured: Pre-dose and at designated time points up to 408 hours post dose
AUC0-Inf of Total [14C]-Radiolabel in Whole Blood
Blood samples will be collected to determine the AUC0-Inf of radiolabeled [14C]-TERN-701.
Measured: Pre-dose and at designated time points up to 408 hours post dose
Cmax of Total [14C]-Radiolabel in Whole Blood
Blood samples will be collected to determine the Cmax of radiolabeled [14C]-TERN-701.
Measured: Pre-dose and at designated time points up to 408 hours post dose
Cumulative Amount of Total [14C]-Radiolabel Excreted in Urine (Aeurine)
Urine samples will be collected to determine the Aeurine of radiolabeled [14C]-TERN-701.
Measured: Pre-dose and at designated time points up to 408 hours post dose
Renal Clearence (CLr) of [14C] radioactivity
Urine samples will be collected to determine the CLr of radiolabeled [14C]-TERN-701.
Measured: Pre-dose and at designated time points up to 408 hours post dose
Percent of Dose Excreted as Radioactivity in Urine (%Feurine) of [14C] radioactivity
Urine samples will be collected to determine the %Feurine of radiolabeled [14C]-TERN-701.
Measured: Pre-dose and at designated time points up to 408 hours post dose
Cumulative Amount of Total [14C]-Radiolabel Excreted in Feces (Aefeces) of [14C] radioactivity
Feces samples will be collected to determine the Aefeces of radiolabeled [14C]-TERN-701.
Measured: Pre-dose and at designated time points up to 408 hours post dose
Percent of Dose Excreted as Radioactivity in Feces (%Fefeces) of [14C] radioactivity
Feces samples will be collected to determine the %Fefeces of radiolabeled [14C]-TERN-701.
Measured: Pre-dose and at designated time points up to 408 hours post dose
Percentage Area Under the Concentration-Time Curve (AUC) of [14C]-Radiolabel TERN-701 Metabolite in Plasma
Blood samples will be collected to determine the Percentage of AUC of [14C]-radiolabel TERN-701 metabolite in plasma.
Measured: Pre-dose and at designated time points up to 408 hours post dose
Percentage of Administered Dose of [14C]-Radiolabel TERN-701 Metabolite in Feces
Feces samples will be collected to determine the percentage of administered dose of [14C]-radiolabel TERN-701 metabolite in feces.
Measured: Pre-dose and at designated time points up to 408 hours post dose
Percentage of the [14C]-Radiolabel TERN-701 Metabolite in Urine
Urine samples will be collected to determine the percentage of [14C]-radiolabel TERN-701 metabolite in urine.
Measured: Pre-dose and at designated time points up to 408 hours post dose
Secondary outcomes (6)
Mean concentration of [14C]-TERN-701 Elimination
Blood, Feces, and Urine samples will be collected to determine the mean concentration of radiolabeled [14C]-TERN-701.
Measured: Pre-dose and at designated time points up to 408 hours post dose
Rate of Elimination of [14C]-TERN-701
Blood, Feces, and Urine samples will be collected to determine the Rate of Elimination of radiolabeled [14C]-TERN-701.
Measured: Pre-dose and at designated time points up to 408 hours post dose
Whole Blood to Plasma Total [14C]-Radiolabel AUC Ratio
Blood samples will be collected to determine the Whole Blood to Plasma AUC Ratio. Calculated as AUC0-Inf of total [14C]-radiolabel in whole blood divided by the AUC0-Inf of Total [14C]-Radiolabel in Plasma.
Measured: Pre-dose and at designated time points up to 408 hours post dose
Number of TERN-701 Metabolite in ≥10% of Total Exposure of [14C]-Radiolabel in Plasma
Blood samples will be collected to determine the number of TERN-701 metabolite that account for ≥10% of total drug-related radiolabeled [14C]-TERN-701 exposure in plasma.
Measured: Pre-dose and at designated time points up to 408 hours post dose
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Measured: Up to approximately 49 days
Number of Participants Who Discontinue Study Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study due to an AE will be reported.
Measured: Up to approximately 18 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start25 Feb 2026
- Primary completion3 Apr 2026
- Study completion3 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839000
- Sponsor's protocol ID
- TERN701-1016
- Other IDs
- MK-4208-002, TERN701-1016
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Mass Balance Study to Investigate the Absorption, Distribution, Metabolism, and Excretion of 14C-TERN-701 Following Administration of a Single Oral Dose in Healthy Adult Male Participants
- ClinicalTrials.gov ID
- NCT07839000
- Acronym / sponsor ID
- TERN701-1016
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Study start
- 25 Feb 2026 (actual)
- Primary completion
- 3 Apr 2026 (actual)
- Study completion
- 3 Apr 2026 (actual)
- First posted
- 24 Sep 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.
The goal of the study is to learn what happens to different forms of TERN-701 medications in a healthy person's body over time. Researchers will compare what happens to different forms of TERN-701 in a person's body over time.
The goal of the study is to learn:
- What happens to different forms of TERN-701 in a person's body over time.
- The amount and number of different forms of TERN-701 that leave a person's body over time.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]-TERN-701 | Experimental | Drug: TERN-701Participants receive a single oral dose of radiolabeled TERN-701 ([14C]-TERN-701) on Day 1. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Has body mass index (BMI) ≥18.5 and ≤32.0 kg/m^2
- Is in good health
Key exclusion criteria (9 listed)
- Has history or presence of any medical condition or prior surgery that may impact typical absorption, distribution, metabolism, or excretion of the orally administered study drug (e.g., gastric bypass, gastrointestinal dysmotility, irritable or inflammatory bowel disease)
- Has history or laboratory evidence of hyperthyroidism (thyroid-stimulating hormone [TSH] < lower limit of normal [LLN]) or hypothyroidism (TSH ≥8 mIU/L)
- Has history of cancer that has not been in complete remission for > 5 years (except basal cell skin cancer or squamous cell skin cancer with a history of curative treatment and no recurrence for > 1 year prior)
- Has history of dysphagia, aspiration, or other conditions that could potentially impede the ability to safely orally ingest the study drug per protocol
- Has history of incomplete bladder emptying with voiding (i.e., urinary retention) or recent history of awakening more than once at night to void
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TERN-701Also: MK-4208, HS-10382Oral Liquid radiolabeled with [14C]-TERN-701 | Drug | [14C]-TERN-701 |
Primary outcome
Percentage of Total Amount of [14C]-Radiolabel Excreted into Urine per Sampling Interval (Aeurine,14C,t1-t2)
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Urine will be collected to determine the Aeurine,14C,t1-t2 of radiolabeled [14C]-TERN-701.
Cumulative Percentage of Total Amount of [14C]-Radiolabel Excreted into Urine up to the Last Sampling Interval (Aeurine,14C)
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Urine will be collected to determine the Aeurine,14C of radiolabeled [14C]-TERN-701.
Percentage of Total Amount of [14C]-Radiolabel Excreted into Feces per Sampling Interval (Aefeces,14C,t1-t2)
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Feces will be collected to determine the Aefeces,14C,t1-t2 of radiolabeled [14C]-TERN-701.
Cumulative Percentage of Total Amount of [14C]-Radiolabel Excreted into Feces Up to the Last Sampling Interval (Aefeces,14C)
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Feces will be collected to determine the Aefeces,14C of radiolabeled [14C]-TERN-701.
Percentage of Total Amount of [14C]-Radiolabel Excreted from Body per Sampling Interval (Aetotal, 14C, t1-t2)
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Urine and Feces will be collected to determine the Aetotal,14C,t1-t2 of radiolabeled [14C]-TERN-701.
Cumulative Percentage of Total Excretion of [14C]-Radiolabel from the Body (Aetotal, 14C)
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Urine and Feces will be collected to determine the Aetotal,14C of radiolabeled [14C]-TERN-701. Calculated as, Aetotal,14C= Aeurine,14C +Aefeces,14C.
Maximum Concentration Observed in Plasma (Cmax) of TERN-701 in Plasma
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Blood samples will be collected to determine the Cmax of TERN-701.
Time to Maximum Concentration Observed in Plasma (Tmax) of TERN-701 in Plasma
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Blood samples will be collected to determine the Tmax of TERN-701.
Apparent Terminal Half-Life (t1/2) of TERN-701 in Plasma
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Blood samples will be collected to determine the t1/2 of TERN-701.
Area Under the Concentration-Time Curve from Time 0 to the Last Quantifiable Concentration (AUC0-last) of TERN-701 in Plasma
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Blood samples will be collected to determine the AUC0-Last of TERN-701.
Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-Inf) of TERN-701 in Plasma
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Blood samples will be collected to determine the AUC0-inf of TERN-701.
Apparent Oral Clearance (CL/F) of TERN-701 in Plasma
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Blood samples will be collected to determine the CL/F of TERN-701.
Apparent Volume of Distribution (Vz/F) of TERN-701 in Plasma
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Blood samples will be collected to determine the Vz/F of TERN-701.
Total [14C]-Radiolabel in Plasma
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Blood samples will be collected to determine the Total [14C]-Radiolabel, calculated as the AUCinf of non-radiolabeled TERN-701 in plasma divided by the AUCinf of total [14C]-radiolabel in plasma.
Tmax of Total [14C]-Radiolabel in Plasma
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Blood samples will be collected to determine the Tmax of radiolabeled [14C]-TERN-701.
t1/2 of Total [14C]-Radiolabel in Plasma
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Blood samples will be collected to determine the t1/2 of radiolabeled [14C]-TERN-701.
AUC0-last of Total [14C]-Radiolabel in Plasma
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Blood samples will be collected to determine the AUC0-last of radiolabeled [14C]-TERN-701.
AUC0-Inf of Total [14C]-Radiolabel in Plasma
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Blood samples will be collected to determine the AUC0-Inf of radiolabeled [14C]-TERN-701.
Cmax of Total [14C]-Radiolabel in Plasma
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Blood samples will be collected to determine the Cmax of radiolabeled [14C]-TERN-701.
Tmax of Total [14C]-Radiolabel in Whole Blood
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Blood samples will be collected to determine the Tmax of radiolabeled [14C]-TERN-701.
t1/2 of Total [14C]-Radiolabel in Whole Blood
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Blood samples will be collected to determine the t1/2 of radiolabeled [14C]-TERN-701.
AUC0-last of Total [14C]-Radiolabel in Whole Blood
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Blood samples will be collected to determine the AUC0-last of radiolabeled [14C]-TERN-701.
AUC0-Inf of Total [14C]-Radiolabel in Whole Blood
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Blood samples will be collected to determine the AUC0-Inf of radiolabeled [14C]-TERN-701.
Cmax of Total [14C]-Radiolabel in Whole Blood
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Blood samples will be collected to determine the Cmax of radiolabeled [14C]-TERN-701.
Cumulative Amount of Total [14C]-Radiolabel Excreted in Urine (Aeurine)
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Urine samples will be collected to determine the Aeurine of radiolabeled [14C]-TERN-701.
Renal Clearence (CLr) of [14C] radioactivity
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Urine samples will be collected to determine the CLr of radiolabeled [14C]-TERN-701.
Percent of Dose Excreted as Radioactivity in Urine (%Feurine) of [14C] radioactivity
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Urine samples will be collected to determine the %Feurine of radiolabeled [14C]-TERN-701.
Cumulative Amount of Total [14C]-Radiolabel Excreted in Feces (Aefeces) of [14C] radioactivity
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Feces samples will be collected to determine the Aefeces of radiolabeled [14C]-TERN-701.
Percent of Dose Excreted as Radioactivity in Feces (%Fefeces) of [14C] radioactivity
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Feces samples will be collected to determine the %Fefeces of radiolabeled [14C]-TERN-701.
Percentage Area Under the Concentration-Time Curve (AUC) of [14C]-Radiolabel TERN-701 Metabolite in Plasma
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Blood samples will be collected to determine the Percentage of AUC of [14C]-radiolabel TERN-701 metabolite in plasma.
Percentage of Administered Dose of [14C]-Radiolabel TERN-701 Metabolite in Feces
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Feces samples will be collected to determine the percentage of administered dose of [14C]-radiolabel TERN-701 metabolite in feces.
Percentage of the [14C]-Radiolabel TERN-701 Metabolite in Urine
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Urine samples will be collected to determine the percentage of [14C]-radiolabel TERN-701 metabolite in urine.
6 secondary outcomes
Mean concentration of [14C]-TERN-701 Elimination
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Rate of Elimination of [14C]-TERN-701
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Whole Blood to Plasma Total [14C]-Radiolabel AUC Ratio
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Number of TERN-701 Metabolite in ≥10% of Total Exposure of [14C]-Radiolabel in Plasma
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 49 days
Number of Participants Who Discontinue Study Due to an AE
Time frame: Up to approximately 18 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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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.
Medical Director study director
Merck Sharp & Dohme LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TERN-701 in people with Healthy, run by Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 24 Sep 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of Total Amount of [14C]-Radiolabel Excreted into Urine per Sampling Interval (Aeurine,14C,t1-t2) (time frame: Pre-dose and at designated time points up to 408 hours post dose). The study lists 32 primary outcomes in all. 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 24 Sep 2026.