CompletedNCT04206657Updated Sep 8, 2021

Pharmacokinetic Study of KHK7580 in Healthy Adult Volunteers

A Phase 1 interventional study of 1mg KHK7580 and 3mg KHK7580 in Healthy Volunteer, sponsored by Kyowa Kirin Co., Ltd.. Completed at 1 site in China. Open to participants aged 20 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-08.

Sponsored by Kyowa Kirin Co., Ltd. · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 42
Allocation: Non-randomized
Ages: 20 Years to 39 Years
Sex: All

Study summary

The primary objective is to evaluate the pharmacokinetic profile of KHK7580 in Chinese healthy adult volunteers. The secondary objective is to evaluate its safety and pharmacodynamics.

Conditions studied

Healthy Volunteer

In context

Lead sponsor

Kyowa Kirin Co., Ltd. is the lead sponsor of 155 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 39 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Personally submitted written voluntary informed consent to participate in the study;
Chinese adult ≥20 and \<40 years of age at informed consent;
BMI ≥18.5 kg/m2 and \<25.0 kg/m2 at screening.

Exclusion criteria

Exclusion Criteria:

Subjects must be excluded from the study if they meet any of the following criteria:

Subjects with present illness requiring treatment;
Subjects in whom the serum Ca concentration, as measured at pretreatment (screening and Day -1) blood chemistry examination, is below the lower limit of the in-house reference value;
Subjects in whom a clinically significant abnormality in the crystalline lens is noted at a pre-study ophthalmological examination;
Subjects with urinary tract lithiasis or its past history;
Subjects with convulsive seizure or its past history;
Subjects with digestive system disorder (peptic ulcer, reflux esophagitis, etc.) or its past history (in this regard, however, a past history of appendicitis is acceptable);
Subjects with mental disorder or its past history;
Subjects who have alcohol/drug dependence or tested positive for any of the drug abuse test items;
Subjects with symptomatic allergy disease;
Subjects with drug allergy or its past history;
Subjects with a past history or family history of congestive heart failure, hypokalemia, or long QT syndrome; Protocol Number: 7580-202 (ver. 1.2) Date: 25 April, 2019 CONFIDENTIAL 7
Subjects in whom a 12-lead ECG tracing before initiation of study drug administration showed, in the judgment of the investigator or subinvestigator, a clinically significant abnormality or an electrocardiographic waveform shape unfit for QT interval measurement;
Subjects who tested positive for any of the infection test items;
Subjects who have used any drugs (including over-the-counter drugs, external preparations, vitamin preparations, and herbal preparations) within 2 weeks before initiation of study drug administration;
Subjects who have smoked a cigarette or used a treatment aid to smoking cessation (including nicotine-containing product chewing/ingestion and nicotine-containing patches) within 2 weeks before initiation of the study drug administration;
Subjects who have participated in a clinical study of a drug and practically received the drug within 4 months before initiation of the study drug administration;
Subjects who, within 3 months before initiation of the study drug administration, have been hospitalized, undergone surgery, or undergone collection of at least 200 mL of blood (including blood donation and blood component donation);
Subjects who did not consent to use an effective contraceptive (e.g., use of condoms) alone or in combination between the day of hospitalization and 3 months after the end of the study drug administration;
Pregnant, lactating, possibly pregnant subjects/women (subjects/women of childbearing potential with positive pregnancy test at screening or Day -1, or with negative pregnancy test at screening and Day -1 not using any contraceptive methods), or unwilling to use adequate contraception according to the physician's instructions. Amenorrhea for ≥12 months after the last menstrual period without an alternative medical cause is considered as non-childbearing potential;
Prior exposure to KHK7580;
Other conditions unfit for participation in this study at the discretion of the investigator or subinvestigator.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Sequential assignment
Masking: None (open label)
Enrollment: 42 participants (actual)

Study arms

Experimental
Single dose administration of 1mg KHK7580
Drug: 1mg KHK7580
Experimental
Single dose administration of 3mg KHK7580
Drug: 3mg KHK7580
Experimental
Single dose administration of 6mg KHK7580
Drug: 6mg KHK7580
Experimental
Single dose administration of 12mg KHK7580
Drug: 12mg KHK7580
Experimental
Multiple dose administration of 6mg KHK7580 for 8days
Drug: 6mg KHK7580 for 8days

Interventions

Drug1mg KHK7580
Single oral dose administration of 1mg KHK7580
Drug3mg KHK7580
Single oral dose administration of 3mg KHK7580
Drug6mg KHK7580
Single oral dose administration of 6mg KHK7580
Drug12mg KHK7580
Single oral dose administration of 12mg KHK7580
Drug6mg KHK7580 for 8days
multiple oral dose administration of 6mg KHK7580 for 8days

What researchers measure

Primary outcomes

Plasma KHK7580 concentration at each time point
Time frame: pre-dose, 0.25, 0.5,1,2,3,4,6,8,12,24,36,48,72 hours post-dose for single dose cohort; pre-dose, 0.25, 0.5,1,2,3,4,8,12,16 hours post dose of Day -1 and pre-dose, 2,4,8,12,16,24,36,48,72,96 hours post-dose of Day 8 for multiple dose cohort
Time to Reach Maximum Observed Plasma Concentration (Tmax) of KHK7580
Time frame: pre-dose, 0.25, 0.5,1,2,3,4,6,8,12,24,36,48,72 hours post-dose for single dose cohort; pre-dose, 0.25, 0.5,1,2,3,4,8,12,16 hours post dose of Day -1 and pre-dose, 2,4,8,12,16,24,36,48,72,96 hours post-dose of Day 8 for multiple dose cohort
Maximum Observed Plasma Concentration (Cmax) of KHK7580
Time frame: pre-dose, 0.25, 0.5,1,2,3,4,6,8,12,24,36,48,72 hours post-dose for single dose cohort; pre-dose, 0.25, 0.5,1,2,3,4,8,12,16 hours post dose of Day -1 and pre-dose, 2,4,8,12,16,24,36,48,72,96 hours post-dose of Day 8 for multiple dose cohort
Area under the plasma concentration-time curve from time 0 to the time of last quantifiable concentration (AUC0-t) of KHK7580
Time frame: pre-dose, 0.25, 0.5,1,2,3,4,6,8,12,24,36,48,72 hours post-dose for single dose cohort; pre-dose, 0.25, 0.5,1,2,3,4,8,12,16 hours post dose of Day -1 and pre-dose, 2,4,8,12,16,24,36,48,72,96 hours post-dose of Day 8 for multiple dose cohort
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of KHK7580
Time frame: pre-dose, 0.25, 0.5,1,2,3,4,6,8,12,24,36,48,72 hours post-dose for single dose cohort; pre-dose, 0.25, 0.5,1,2,3,4,8,12,16 hours post dose of Day -1 and pre-dose, 2,4,8,12,16,24,36,48,72,96 hours post-dose of Day 8 for multiple dose cohort
Plasma Half-Life (t1/2) of KHK7580
Time frame: pre-dose, 0.25, 0.5,1,2,3,4,6,8,12,24,36,48,72 hours post-dose for single dose cohort; pre-dose, 0.25, 0.5,1,2,3,4,8,12,16 hours post dose of Day -1 and pre-dose, 2,4,8,12,16,24,36,48,72,96 hours post-dose of Day 8 for multiple dose cohort
Apparent systemic clearance (CL/F) of KHK7580
Time frame: pre-dose, 0.25, 0.5,1,2,3,4,6,8,12,24,36,48,72 hours post-dose for single dose cohort; pre-dose, 0.25, 0.5,1,2,3,4,8,12,16 hours post dose of Day -1 and pre-dose, 2,4,8,12,16,24,36,48,72,96 hours post-dose of Day 8 for multiple dose cohort

Secondary outcomes

Incidence of treatment emergent adverse events (TEAEs)
Time frame: Dosing to study completion
QTcF
Time frame: [Single dose] baseline to Day 4; [Multiple dose] baseline to Day 12
QTcB
Time frame: [Single dose] baseline to Day 4; [Multiple dose] baseline to Day 12
intact PTH level
Time frame: [Single dose] baseline to Day 4; [Multiple dose] baseline to Day 12
serum P level
Time frame: [Single dose] baseline to Day 4; [Multiple dose] baseline to Day 12

Study locations

1 site

Beijing hospital
Beijing, Beijing, China

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04206657
Lead sponsor: Kyowa Kirin Co., Ltd.
Collaborators: Kyowa Kirin China Pharmaceutical Co., Ltd.
Responsible party: Sponsor
First posted: Dec 20, 2019
Start date: Dec 20, 2019
Primary completion: Jun 17, 2021
Completion: Jun 17, 2021
Last update: Sep 8, 2021

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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