A Clinical Trial to Evaluate [14C]-MK-4208/[14C]-TERN-701 in Healthy Adult Male Participants (MK-4208-002/TERN701-1016)

NCT07839000 — Phase 1, Completed, 8 participants, Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

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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

RegistryNCT07839000
StatusCompleted
PhasePhase 1
Study typeInterventional; na, single group, masking: none, basic science
Enrollment8 (Actual)
SponsorTerns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) (Industry)
ConditionsHealthy
InterventionsTERN-701 (Drug)
Datesstart 2026-02-25, primary completion 2026-04-03, completion 2026-04-03, first posted 2026-09-24, last updated 2026-09-24
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Healthy All trials of TERN-701

-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.

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.

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+Arms and interventions

ArmTypeInterventionsDescription
[14C]-TERN-701ExperimentalDrug: TERN-701Participants receive a single oral dose of radiolabeled TERN-701 (\[14C\]-TERN-701) on Day 1.
  • TERN-701 (Drug), also known as MK-4208, HS-10382: Oral Liquid radiolabeled with \[14C\]-TERN-701

+Outcome measures

Primary outcomes

  • Percentage of Total Amount of [14C]-Radiolabel Excreted into Urine per Sampling Interval (Aeurine,14C,t1-t2) [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) [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) [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) [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) [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) [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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) [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 [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 [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 [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 [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 [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 [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 [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.

Secondary outcomes

  • Mean concentration of [14C]-TERN-701 Elimination [Pre-dose and at designated time points up to 408 hours post dose]: Blood, Feces, and Urine samples will be collected to determine the mean concentration of radiolabeled \[14C\]-TERN-701.
  • Rate of Elimination of [14C]-TERN-701 [Pre-dose and at designated time points up to 408 hours post dose]: Blood, Feces, and Urine samples will be collected to determine the Rate of Elimination of radiolabeled \[14C\]-TERN-701.
  • Whole Blood to Plasma Total [14C]-Radiolabel AUC Ratio [Pre-dose and at designated time points up to 408 hours post dose]: 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.
  • Number of TERN-701 Metabolite in ≥10% of Total Exposure of [14C]-Radiolabel in Plasma [Pre-dose and at designated time points up to 408 hours post dose]: 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.
  • Number of Participants Who Experience an Adverse Event (AE) [Up to approximately 49 days]: 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.
  • Number of Participants Who Discontinue Study Due to an AE [Up to approximately 18 days]: 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.

+Eligibility

Sex: Male, ages: 18 Years to 55 Years, accepts healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
* 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

+Locations (1)

FacilityCityCountryStatus
Pharmaron CPC IncBaltimore, MarylandUnited States

+Investigators

  • Medical Director, Study director, Merck Sharp & Dohme LLC