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Phase 1 Completed N=24 Randomized Double-blind Other

Phase 1 TAK-906 Single and Multiple Ascending Dose Study in Japanese Healthy Male Participants

Japanese Healthy Adult Male Participants
Source: ClinicalTrials.gov NCT03237156 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcomePrimary: Number of Participants Who Experience at Least One Treatment-Emergent Adverse Event (TEAE) — 1; 0; 2; 1 Participants

Summary

The purpose of this study is to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of TAK-906 in Japanese healthy male participants.

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants Who Experience at Least One Treatment-Emergent Adverse Event (TEAE)
1; 0; 2; 1
PRIMARY
Number of Participants With Markedly Abnormal Values of Vital Signs
2; 1; 2; 1; 3; 2
PRIMARY
Number of Participants With Markedly Abnormal Values of Clinical Laboratory Test Results
0; 0; 0; 0
PRIMARY
Number of Participants With Markedly Abnormal Values of 12-lead Electrocardiogram (ECG)
3; 1; 3; 2; 1; 0
PRIMARY
Number of Participants With TEAEs Related to Physical Examinations
0; 0; 0; 0
SECONDARY
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period
72.58; 156.9; 13.71; 7.869; 16.05; 1.602
SECONDARY
Cmax: Maximum Observed Plasma Concentration for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period
35.31; 58.21; 6.951; 3.082; 4.412; 0.5088
SECONDARY
AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period
70.96; 149.1; 13.47; 7.608; 14.69; 1.327
SECONDARY
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period
1.000; 1.000; 1.000; 1.000; 1.000; 1.000
SECONDARY
t1/2z: Terminal Disposition Phase Half-life for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period
4.692; 5.152; 1.894; 2.483; 4.423; 3.170
SECONDARY
Ae(0-24): Amount of Drug Excreted in Urine From Time 0 to 24 Hours Postdose for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period
741.2; 1571; 160.0; 64.57; 135.2; 13.27
SECONDARY
Fe24: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to 24 Hours for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose
1.815; 1.923; 1.959; 0.1575; 0.1648; 0.1618
SECONDARY
CLR: Renal Clearance for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period
10.31; 9.741; 11.76; 8.021; 7.782; 9.204
SECONDARY
AUC(τ,ss): Area Under the Plasma Concentration-time Curve From Time 0 During Dosing Interval at Steady State for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period
89.01; 186.6; 16.28; 9.881; 25.35; 1.672
SECONDARY
Cmax,ss: Maximum Observed Plasma Concentration During Dosing Interval at Steady State for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period
46.47; 79.36; 7.642; 3.858; 8.119; 0.5309
SECONDARY
Tmax,ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period
1.000; 1.250; 1.000; 1.000; 1.500; 1.000
SECONDARY
t1/2z: Terminal Disposition Phase Half-life for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period
6.447; 4.407; 3.727; 5.573; 4.598; 3.037
SECONDARY
Aetau: Amount of Drug Excreted in Urine During a Dosing Interval for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period
895.8; 2155; 198.7; 78.75; 237.7; 16.11
SECONDARY
Fetau: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time Tau Over the Dosing Interval for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period
2.193; 2.638; 2.432; 0.1921; 0.2898; 0.1965
SECONDARY
CLR: Renal Clearance for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period
10.04; 11.50; 12.21; 7.744; 8.669; 9.113
SECONDARY
AUCtau: Area Under the Serum Concentration-time Curve During a Dosing Interval for Serum Prolactin on Day 1 of Single Dose Period
79.66; 362.9; 398.7; 317.4
SECONDARY
Cmax: Maximum Observed Serum Concentration for Serum Prolactin on Day 1 of Single Dose Period
10.68; 73.12; 81.09; 82.33
SECONDARY
AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Serum Prolactin on Day 1 of Single Dose Period
174.5; 544.9; 638.8; 449.9
SECONDARY
AUC(t,ss): Area Under the Serum Concentration-time Curve From Time 0 During Dosing Interval at Steady State for Serum Prolactin on Day 7 of Multiple Dose Period
75.40; 354.8; 476.2; 317.0
SECONDARY
Cmax,ss: Maximum Observed Serum Concentration During Dosing Interval at Steady State for Serum Prolactin on Day 7 of Multiple Dose Period
11.48; 39.65; 55.89; 71.02

Eligibility Criteria

Inclusion Criteria

  • In the opinion of the investigator or sub-investigator, the participant is capable of understanding and complying with protocol requirements.
  • The participant signs and dates a written, informed consent form prior to the initiation of any study procedures.
  • The participant is a Japanese healthy adult male, aged 20 to 60 years, inclusive, at the time of informed consent.
  • The participant weighs at least 50 kilogram (kg) and has a body mass index (BMI) from 18.5 to 25 kilogram per square meter (kg/m^2), inclusive at Screening.
  • A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from the signing of informed consent to 12 weeks (84 days) after the last dose of study drug. The female partner of a male participant should also be advised to use adequate contraception.

Exclusion Criteria

  • The participant has received any investigational compound within 16 weeks (112 days) prior to the first dose of study drug.
  • The participant has received TAK-906 in a previous clinical study or as a therapeutic agent.
  • The participant is an immediate family member of or an investigational site employee, or is in a dependent relationship with an investigational site employee who is involved in the conduct of this study (example, spouse, parent, child, sibling) or may consent under duress.
  • The participant has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality, which may impact the ability of the participant to participate in the study or potentially confound its results.
  • The participant has a history of any psychiatric disease that would interfere with the evaluation of study drug activity (prolactin concentration) or safety.
  • The participant has a history of seizure or tardive dyskinesia.
  • The participant has a history of hyperprolactinemia, pituitary adenoma, and/or hypothyroidism.
  • The participant has a family history of prolonged QT.
  • The participant has undergone previous gastric bypass surgery or currently had a gastric band fitted.
  • The participant has dysphagia and/or inability to swallow study medication whole.
  • The participant has a known hypersensitivity to any component of the TAK-906 formulation or related compounds.
  • The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 2 years prior to the Screening visit, or is unwilling to agree to abstain from alcohol and drugs throughout the study, or has a positive urine test result for drugs of abuse or a positive alcohol screen (urine alcohol test/breath test) result for alcohol at Screening.
  • The participant has taken any excluded medication, supplements, or dietary products during the time periods listed in the Excluded Medications, Supplements, and Dietary Products table.
  • If male, the participant intends to donate sperm during the course of this study or for at least 12 weeks (84 days) after the last dose of study drug.
  • The participant has current or recent (within 24 weeks [168 days]) gastrointestinal disease that would be expected to influence the absorption of drugs (that is, a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent [more than once per week] occurrence of heartburn, or any surgical intervention).
  • The participant has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Day 1.
  • The participant has a positive test result for hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody/antigen, or serological reactions for syphilis at Screening.
  • The participant has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03237156). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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