NCT02792062

A Food Effect Study of TAK-385 Final Formulation

Completed Phase 1 Results posted Last updated 18 December 2017

What this trial tests

Phase 1 trial testing TAK-385 40 mg in Japanese Premenopausal Healthy Adult Women in 12 participants. Completed in 31 August 2016.

Timeline

4 July 2016

Primary endpoint
31 August 2016

31 August 2016

Quick facts

Lead sponsor	Takeda
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	4 July 2016
Primary completion	31 August 2016
Estimated completion	31 August 2016
Sites	1 location across Japan

Drugs / interventions tested

• TAK-385 40 mg — full drug profile →

Conditions studied

• Japanese Premenopausal Healthy Adult Women — all drugs for Japanese Premenopausal Healthy Adult Women →

Sponsor

Takeda — full company profile →

Who can join

Adults 20 to 45, female only, with Japanese Premenopausal Healthy Adult Women. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Cmax: Maximum Observed Plasma Concentration for TAK-385 Primary · Day 1: Pre-dose and at multiple time points (up to 120 hrs) post-dose

Group	Value	95% CI
TAK-385 40 mg Fasted	23.44	± 17.822
TAK-385 40 mg Before Breakfast	29.05	± 22.868
TAK-385 40 mg After Breakfast	10.94	± 9.3726

AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385 Primary · Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, and 120hrs; up to 120 hrs) post-dose

Group	Value	95% CI
TAK-385 40 mg Fasted	160.5	± 75.187
TAK-385 40 mg Before Breakfast	139.1	± 65.653
TAK-385 40 mg After Breakfast	79.65	± 33.426

AUC(0-120): Area Under the Plasma Concentration-time Curve From Time 0 to 120 Hours Postdose for TAK-385 Primary · Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, and 120hrs; up to 120 hrs) post-dose

Group	Value	95% CI
TAK-385 40 mg Fasted	149.3	± 70.354
TAK-385 40 mg Before Breakfast	130.2	± 61.549
TAK-385 40 mg After Breakfast	73.25	± 30.726

AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-385 Primary · Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, and 120hrs; up to 120 hrs) post-dose

Group	Value	95% CI
TAK-385 40 mg Fasted	149.3	± 70.354
TAK-385 40 mg Before Breakfast	130.2	± 61.549
TAK-385 40 mg After Breakfast	73.25	± 30.726

Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) or Serious TEAEs. Secondary · Day 1 up to 12 days after the last dose of study drug (Day 41)

TEAEs

Group	Value	95% CI
TAK-385 40 mg Fasted	5
TAK-385 40 mg Before Breakfast	5
TAK-385 40 mg After Breakfast	3

Serious TEAEs

Group	Value	95% CI
TAK-385 40 mg Fasted	0
TAK-385 40 mg Before Breakfast	0
TAK-385 40 mg After Breakfast	0

Number of Participants With TEAEs Related to Vital Signs (Presyncope) Secondary · Day 1 up to 12 days after last dose of study drug (Day 41)

Group	Value	95% CI
TAK-385 40 mg Fasted	0
TAK-385 40 mg Before Breakfast	1
TAK-385 40 mg After Breakfast	0

Number of Participants With TEAEs Related to Body Weight Secondary · Day 1 up to 12 days after last dose of study drug (Day 41)

Group	Value	95% CI
TAK-385 40 mg Fasted	0
TAK-385 40 mg Before Breakfast	0
TAK-385 40 mg After Breakfast	0

Number of Participants With TEAEs Related to Electrocardiograms (ECG) Secondary · Day 1 up to 12 days after last dose of study drug (Day 41)

Group	Value	95% CI
TAK-385 40 mg Fasted	0
TAK-385 40 mg Before Breakfast	0
TAK-385 40 mg After Breakfast	0

Number of Participants With TEAEs Related to Clinical Laboratory Tests Secondary · Day 1 up to 12 days after last dose of study drug (Day 41)

Clinical laboratory tests included hematology, serum chemistry, and urinalysis.

Group	Value	95% CI
TAK-385 40 mg Fasted	0
TAK-385 40 mg Before Breakfast	0
TAK-385 40 mg After Breakfast	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 12 days (Day 41) after the last dose of study drug. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

TAK-385 40 mg Fasted

Serious: 0/12 (0%)

Deaths: —

TAK-385 40 mg Before Breakfast

Serious: 0/12 (0%)

Deaths: —

TAK-385 40 mg After Breakfast

Serious: 0/11 (0%)

Deaths: —

Other adverse events (9 terms — click to expand)

Reaction	System	TAK-385 40 mg Fasted	TAK-385 40 mg Before Break…	TAK-385 40 mg After Breakf…
Metrorrhagia	Reproductive system and breast disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Abdominal pain lower	Gastrointestinal disorders	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Presyncope	Nervous system disorders	—	—	—
Menstruation irregular	Reproductive system and breast disorders	—	—	—

Data from ClinicalTrials.gov NCT02792062 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate food effects on the pharmacokinetics of a single oral dose of TAK-385 in Japanese premenopausal healthy adult women.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Phase I trial of TAK-385 in hormone treatment-naïve Japanese patients with nonmetastatic prostate cancer.
   Suzuki H, Uemura H, Mizokami A, Hayashi N, et al · · 2019 · cited 29× · PMID 31429205 · DOI 10.1002/cam4.2442