Trial Outcomes & Findings for A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of TAK-123 After Intravenous Infusion in Japanese Healthy Adult Male Participants (NCT NCT04155567)
NCT ID: NCT04155567
Last Updated: 2025-11-20
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
10 participants
Primary outcome timeframe
Day 1: pre-infusion and 0.25, 0.75, 1.5, 2.5, 4.5, 6.5, 8.5, 10.5, 12.5, 16.5, 25.5, 26, 26.5, 27, 27.5, 28, 28.5, 29.5, 30.5, 32.5 and 48 hours post-infusion
Results posted on
2025-11-20
Participant Flow
Participants took part in the study at 1 investigative site in Japan from 13 November 2019 to 06 December 2019.
Healthy Japanese male participants were enrolled in the study to receive TAK-123 3.75 gram per square meter (g/m\^2) sodium phenylacetate (NaPA) and 3.75 g/m\^2 sodium benzoate (NaBZ), as loading dose followed by an equivalent maintenance dose.
Participant milestones
| Measure |
TAK-123 3.75 g/m^2 NaPA and NaBZ
TAK-123 3.75 g/m\^2 NaPA and TAK-123 3.75 g/m\^2 NaBZ as loading dose, infusion, intravenously over 90 minutes, followed by TAK-123 3.75 g/m\^2 NaPA and TAK-123 3.75 g/m\^2 NaBZ maintenance dose, infusion, intravenously over 24 hours on Day 1.
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Overall Study
STARTED
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10
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Overall Study
COMPLETED
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10
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
TAK-123 3.75 g/m^2 NaPA and NaBZ
n=10 Participants
TAK-123 3.75 g/m\^2 NaPA and TAK-123 3.75 g/m\^2 NaBZ as loading dose, infusion, intravenously over 90 minutes, followed by TAK-123 3.75 g/m\^2 NaPA and TAK-123 3.75 g/m\^2 NaBZ maintenance dose, infusion, intravenously over 24 hours on Day 1.
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Age, Continuous
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33.1 years
STANDARD_DEVIATION 5.09 • n=10 Participants
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Sex: Female, Male
Female
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0 Participants
n=10 Participants
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Sex: Female, Male
Male
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10 Participants
n=10 Participants
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Region of Enrollment
Japan
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10 Participants
n=10 Participants
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Height
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173.7 centimeter (cm)
STANDARD_DEVIATION 5.03 • n=10 Participants
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Weight
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65.68 kilogram (kg)
STANDARD_DEVIATION 6.994 • n=10 Participants
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Body Mass Index (BMI)
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21.74 kilogram per square meter (kg/m˄2)
STANDARD_DEVIATION 1.532 • n=10 Participants
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Smoking Classification
Never Smoked
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8 Participants
n=10 Participants
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Smoking Classification
Former Smoker
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2 Participants
n=10 Participants
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Alcohol Classification
Drank A Few Times Per Month
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5 Participants
n=10 Participants
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Alcohol Classification
Never Drank
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5 Participants
n=10 Participants
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Caffeine Classification
Had Caffeine Consumption
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1 Participants
n=10 Participants
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Caffeine Classification
Had No Caffeine Consumption
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9 Participants
n=10 Participants
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PRIMARY outcome
Timeframe: Day 1: pre-infusion and 0.25, 0.75, 1.5, 2.5, 4.5, 6.5, 8.5, 10.5, 12.5, 16.5, 25.5, 26, 26.5, 27, 27.5, 28, 28.5, 29.5, 30.5, 32.5 and 48 hours post-infusionPopulation: The pharmacokinetics (PK) analysis set was defined as all participants who received at least one dose of TAK-123 and provided sufficient PK measurements available to estimate at least one estimable PK parameter.
Outcome measures
| Measure |
TAK-123 3.75 g/m^2 NaPA and NaBZ
n=10 Participants
TAK-123 3.75 g/m\^2 NaPA and TAK-123 3.75 g/m\^2 NaBZ as loading dose, infusion, intravenously over 90 minutes, followed by TAK-123 3.75 g/m\^2 NaPA and TAK-123 3.75 g/m\^2 NaBZ maintenance dose, infusion, intravenously over 24 hours on Day 1.
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Cmax: Maximum Observed Plasma Concentration for Phenylacetate, Benzoate, and Their Metabolites (Phenylacetylglutamine and Hippurate)
Phenylacetate
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300.7 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 5.2
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Cmax: Maximum Observed Plasma Concentration for Phenylacetate, Benzoate, and Their Metabolites (Phenylacetylglutamine and Hippurate)
Benzoate
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233.2 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 6.9
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Cmax: Maximum Observed Plasma Concentration for Phenylacetate, Benzoate, and Their Metabolites (Phenylacetylglutamine and Hippurate)
Phenylacetylglutamine
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69.77 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 19.8
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Cmax: Maximum Observed Plasma Concentration for Phenylacetate, Benzoate, and Their Metabolites (Phenylacetylglutamine and Hippurate)
Hippurate
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54.13 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 18.0
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PRIMARY outcome
Timeframe: Day 1: pre-infusion and 0.25, 0.75, 1.5, 2.5, 4.5, 6.5, 8.5, 10.5, 12.5, 16.5, 25.5, 26, 26.5, 27, 27.5, 28, 28.5, 29.5, 30.5, 32.5 and 48 hours post-infusionPopulation: The PK analysis set was defined as all participants who received at least one dose of TAK-123 and provided sufficient PK measurements available to estimate at least one estimable PK parameter.
Outcome measures
| Measure |
TAK-123 3.75 g/m^2 NaPA and NaBZ
n=10 Participants
TAK-123 3.75 g/m\^2 NaPA and TAK-123 3.75 g/m\^2 NaBZ as loading dose, infusion, intravenously over 90 minutes, followed by TAK-123 3.75 g/m\^2 NaPA and TAK-123 3.75 g/m\^2 NaBZ maintenance dose, infusion, intravenously over 24 hours on Day 1.
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AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Phenylacetate, Benzoate, and Their Metabolites (Phenylacetylglutamine and Hippurate)
Phenylacetylglutamine
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1135 hour*microgram per milliliter (h*mcg/mL)
Geometric Coefficient of Variation 16.2
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AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Phenylacetate, Benzoate, and Their Metabolites (Phenylacetylglutamine and Hippurate)
Hippurate
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413.5 hour*microgram per milliliter (h*mcg/mL)
Geometric Coefficient of Variation 22.2
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AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Phenylacetate, Benzoate, and Their Metabolites (Phenylacetylglutamine and Hippurate)
Phenylacetate
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3931 hour*microgram per milliliter (h*mcg/mL)
Geometric Coefficient of Variation 22.6
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AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Phenylacetate, Benzoate, and Their Metabolites (Phenylacetylglutamine and Hippurate)
Benzoate
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752.6 hour*microgram per milliliter (h*mcg/mL)
Geometric Coefficient of Variation 16.7
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PRIMARY outcome
Timeframe: Day 1: pre-infusion and 0.25, 0.75, 1.5, 2.5, 4.5, 6.5, 8.5, 10.5, 12.5, 16.5, 25.5, 26, 26.5, 27, 27.5, 28, 28.5, 29.5, 30.5, 32.5 and 48 hours post-infusionPopulation: The PK analysis set was defined as all participants who received at least one dose of TAK-123 and provided sufficient PK measurements available to estimate at least one estimable PK parameter. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given categories.
Outcome measures
| Measure |
TAK-123 3.75 g/m^2 NaPA and NaBZ
n=10 Participants
TAK-123 3.75 g/m\^2 NaPA and TAK-123 3.75 g/m\^2 NaBZ as loading dose, infusion, intravenously over 90 minutes, followed by TAK-123 3.75 g/m\^2 NaPA and TAK-123 3.75 g/m\^2 NaBZ maintenance dose, infusion, intravenously over 24 hours on Day 1.
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AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Phenylacetate, Benzoate, and Their Metabolites (Phenylacetylglutamine and Hippurate)
Phenylacetate
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3932 h*mcg/mL
Geometric Coefficient of Variation 22.6
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AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Phenylacetate, Benzoate, and Their Metabolites (Phenylacetylglutamine and Hippurate)
Phenylacetylglutamine
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1140 h*mcg/mL
Geometric Coefficient of Variation 16.4
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AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Phenylacetate, Benzoate, and Their Metabolites (Phenylacetylglutamine and Hippurate)
Hippurate
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427.3 h*mcg/mL
Geometric Coefficient of Variation 21.2
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SECONDARY outcome
Timeframe: Day 1 up to Day 8Population: The safety analysis set was defined as all participants who received at least one dose of TAK-123.
Outcome measures
| Measure |
TAK-123 3.75 g/m^2 NaPA and NaBZ
n=10 Participants
TAK-123 3.75 g/m\^2 NaPA and TAK-123 3.75 g/m\^2 NaBZ as loading dose, infusion, intravenously over 90 minutes, followed by TAK-123 3.75 g/m\^2 NaPA and TAK-123 3.75 g/m\^2 NaBZ maintenance dose, infusion, intravenously over 24 hours on Day 1.
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Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
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6 Participants
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Adverse Events
TAK-123 3.75 g/m^2 NaPA and NaBZ
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TAK-123 3.75 g/m^2 NaPA and NaBZ
n=10 participants at risk
TAK-123 3.75 g/m\^2 NaPA and TAK-123 3.75 g/m\^2 NaBZ as loading dose, infusion, intravenously over 90 minutes, followed by TAK-123 3.75 g/m\^2 NaPA and TAK-123 3.75 g/m\^2 NaBZ maintenance dose, infusion, intravenously over 24 hours on Day 1.
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Cardiac disorders
Sinus tachycardia
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20.0%
2/10 • TEAEs are adverse events (AEs) that started after first dose of study drug up to Day 8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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Gastrointestinal disorders
Nausea
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10.0%
1/10 • TEAEs are adverse events (AEs) that started after first dose of study drug up to Day 8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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Metabolism and nutrition disorders
Hyperglycaemia
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10.0%
1/10 • TEAEs are adverse events (AEs) that started after first dose of study drug up to Day 8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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Nervous system disorders
Headache
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20.0%
2/10 • TEAEs are adverse events (AEs) that started after first dose of study drug up to Day 8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
- Publication restrictions are in place
Restriction type: OTHER