Trial Outcomes & Findings for Pharmacokinetic Interaction Between HGP0904, HGP0608 and HGP1405 (NCT NCT02387554)

NCT ID: NCT02387554

Last Updated: 2015-06-12

Results Overview

AUClast(Area under the curve to the last measurable concentration)

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

33 participants

Primary outcome timeframe

0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr

Results posted on

2015-06-12

Participant Flow

Participant milestones

Participant milestones
Measure	Sequence 1 Period 1 : A (Amlodipine 10mg PO single dose) Period 2 : L (Losartan 100mg PO single dose) Period 3 : ALC (Amlodipine 10mg + Losartan 100mg + Chlorthalidone 25mg PO single dose) Period 4 : C (Chlorthalidone 25mg PO single dose)	Sequence 2 Period 1 : L (Losartan 100mg PO single dose) Period 2 : C (Chlorthalidone 25mg PO single dose) Period 3 : A (Amlodipine 10mg PO single dose) Period 4 : ALC (Amlodipine 10mg + Losartan 100mg + Chlorthalidone 25mg PO single dose)	Sequence 3 Period 1 : C (Chlorthalidone 25mg PO single dose) Period 2 : ALC (Amlodipine 10mg + Losartan 100mg + Chlorthalidone 25mg PO single dose) Period 3 : L (Losartan 100mg PO single dose) Period 4 : A (Amlodipine 10mg PO single dose)	Sequence 4 Period 1 : ALC (Amlodipine 10mg + Losartan 100mg + Chlorthalidone 25mg PO single dose) Period 2 : A (Amlodipine 10mg PO single dose) Period 3 : C (Chlorthalidone 25mg PO single dose) Period 4 : L (Losartan 100mg PO single dose)
Overall Study STARTED	10	7	8	8
Overall Study COMPLETED	7	7	6	6
Overall Study NOT COMPLETED	3	0	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacokinetic Interaction Between HGP0904, HGP0608 and HGP1405

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sequence 1 n=10 Participants Period 1 : A Period 2 : L Period 3 : ALC Period 4 : C	Sequence 2 n=7 Participants Period 1 : L Period 2 : C Period 3 : A Period 4 : ALC	Sequence 3 n=8 Participants Period 1 : C Period 2 : ALC Period 3 : L Period 4 : A	Sequence 4 n=8 Participants Period 1 : ALC Period 2 : A Period 3 : C Period 4 : L	Total n=33 Participants Total of all reporting groups
Age, Continuous	26.70 years STANDARD_DEVIATION 4.06 • n=5 Participants	26.43 years STANDARD_DEVIATION 4.89 • n=7 Participants	26.00 years STANDARD_DEVIATION 3.93 • n=5 Participants	24.88 years STANDARD_DEVIATION 4.05 • n=4 Participants	26.06 years STANDARD_DEVIATION 4.07 • n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	8 Participants n=4 Participants	33 Participants n=21 Participants
Region of Enrollment Korea, Republic of	10 participants n=5 Participants	7 participants n=7 Participants	8 participants n=5 Participants	8 participants n=4 Participants	33 participants n=21 Participants

PRIMARY outcome

Timeframe: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr

AUClast(Area under the curve to the last measurable concentration)

Outcome measures

Outcome measures
Measure	HGP0904 n=28 Participants HGP0904(amlodipine) ratio in single or combination	HGP0608 n=27 Participants HGP0608(losartan) ratio in single or combination	HGP1405 n=27 Participants HGP1405(chlorthalidone) ratio in single or combination	EXP3174 n=27 Participants EXP3174(losartan active metabolite) ratio in single or combination
AUClast	1.0360 Ratio(Comb/Alone) Interval 0.9958 to 1.0778	1.1606 Ratio(Comb/Alone) Interval 1.0885 to 1.2375	1.0266 Ratio(Comb/Alone) Interval 0.9752 to 1.0807	1.0902 Ratio(Comb/Alone) Interval 1.035 to 1.1148

PRIMARY outcome

Timeframe: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr

Cmax(maxium concentration)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr

AUCinf(Area under the curve to infinity)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr

Tmax(Time to maximum concentration)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr

T1/2(Terminal elimination half-life),

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr

CL/F(Apparent clearance)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr

Vz/F(Apparent volume of distribution)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Outcome measures

Outcome data not reported

Adverse Events

HGP0904

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

HGP0608

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

HGP1405

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

HGP0904+HGP0608+HGP1405

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	HGP0904 n=28 participants at risk amlodipine HGP0904	HGP0608 n=27 participants at risk losartan HGP0608	HGP1405 n=27 participants at risk chlorthalidone HGP1405	HGP0904+HGP0608+HGP1405 n=28 participants at risk amlodipine + losartan + chlorthalidone HGP0904 HGP0608 HGP1405
Infections and infestations Meningitis	3.6% 1/28 • Number of events 1	0.00% 0/27	0.00% 0/27	0.00% 0/28

Other adverse events

Other adverse events
Measure	HGP0904 n=28 participants at risk amlodipine HGP0904	HGP0608 n=27 participants at risk losartan HGP0608	HGP1405 n=27 participants at risk chlorthalidone HGP1405	HGP0904+HGP0608+HGP1405 n=28 participants at risk amlodipine + losartan + chlorthalidone HGP0904 HGP0608 HGP1405
Gastrointestinal disorders Nausea	0.00% 0/28	0.00% 0/27	0.00% 0/27	7.1% 2/28 • Number of events 2

Additional Information

Principal Investigator

Bundang Seoul National University Hospital

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place