CompletedNCT01154634Updated Aug 30, 2012Results posted

Study to Investigate the Pharmacodynamic Effect of a Single Dose of AZD2516 in Healthy Male Subjects

A Phase 2 interventional study of AZD2516, 5 mg and AZD2516, 16 mg in Reflux, sponsored by AstraZeneca. Completed at 2 sites in 2 countries. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-08-30.

Sponsored by AstraZeneca · Phase 2, Interventional, and Basic science

Phase: Phase 2
Study type: Interventional
Enrollment: 20
Allocation: Randomized
Ages: 18 Years to 45 Years
Sex: Male

Study summary

The purpose of this study is to investigate the pharmacodynamic effect of AZD2516 in healthy male subjects.

Read the detailed description

A double-blind, randomized, placebo-controlled, two-centre, phase IIa pharmacodynamic cross-over study to assess the effect of AZD2516 on the total number of reflux episodes in healthy male volunteers.

Conditions studied

Reflux

Browse trials for

Gastroesophageal Reflux 1,067

Keywords

Pharmacodynamic effect
Reflux inhibition

In context

Gastroesophageal Reflux

1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.

This study's enrollment of 20 is below the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

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

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

Inclusion criteria

Provision of signed informed consent
Healthy male subjects
Age 18-45 years, inclusive

Exclusion criteria

Exclusion Criteria:

Clinically significant illness within the 2 weeks prior to the first dose of study drug
History of clinically significant cardiovascular, respiratory, renal, hepatic, neurological, mental or gastrointestinal disease
Need for concomitant medications during the study

Study design

Phase: Phase 2
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 20 participants (actual)

Study arms

Experimental
First 5 mg, then placebo, then 16 mg, then 40 mg
period 1: AZD2516 5 mg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD2516 16 mg, period 6: washout, period 7: AZD2516 40 mg.
Drug: AZD2516, 5 mg · Drug: AZD2516, 16 mg · Drug: AZD2516, 40 mg · Drug: Placebo
Experimental
First 40 mg, then 16 mg, then placebo, then 5 mg
period 1: AZD2516 40 mg, period 2: washout, period 3: AZD2516 16 mg, period 4: washout, period 5: placebo, period 6: washout, period 7: AZD2516 5 mg.
Drug: AZD2516, 5 mg · Drug: AZD2516, 16 mg · Drug: AZD2516, 40 mg · Drug: Placebo
Experimental
First 16 mg, then 5 mg, then 40 mg, then placebo
period 1: AZD2516 16 mg, period 2: washout, period 3: AZD2516 5 mg, period 4: washout, period 5: AZD2516 40 mg, period 6: washout, period 7: placebo.
Drug: AZD2516, 5 mg · Drug: AZD2516, 16 mg · Drug: AZD2516, 40 mg · Drug: Placebo
Experimental
First placebo, then 40 mg, then 5 mg, then 16 mg
period 1: placebo, period 2: washout, period 3: AZD2516 40 mg, period 4: washout, period 5: AZD2516 5 mg, period 6: washout, period 7: AZD2516 16 mg
Drug: AZD2516, 5 mg · Drug: AZD2516, 16 mg · Drug: AZD2516, 40 mg · Drug: Placebo

Interventions

DrugAZD2516, 5 mg
Capsule, oral
DrugAZD2516, 16 mg
Capsule, oral
DrugAZD2516, 40 mg
Capsule, oral
DrugPlacebo
Capsule, oral

What researchers measure

Primary outcomes

Reflux Episodes 0 to 3 Hours Post Meal
Total number of reflux episodes 0 to 3 hours post meal
Time frame: 0 to 3 hours post meal

Secondary outcomes

Transient Lower Esophagus Sphincter Relaxations (TLESRs) 0 to 3 Hours Post Meal
Number of TLESRs 0 to 3 hours post meal were calculated based upon the manometric analysis fpr the 3-hour post-meal period.
Time frame: 0 to 3 hours post meal
Area Under the Plasma Concentration Curve(AUC)
Area under the plasma concentration vs. time curve from time zero to 12-hours post dose calculated by loglinear trapezoidal method
Time frame: 0 to 12 hours post dose
Average Plasma Concentration (C Average)
Average plasma concentration
Time frame: 1 to 4 hours post dose
Maximum Plasma Concentration (Cmax)
Maximum plasma concentration
Time frame: 0 to 12 hours post dose
Time to Maximum Plasma Concentration (Tmax)
Time to maximum plasma concentration (Tmax)
Time frame: 0 to 12 hours post dose
Terminal Half-life (T Half)
Terminal half-life (T half)
Time frame: 0 to 12 hours post dose
Clinically Relevant Change of Laboratory Variables
Number of participants with clinically relevant change of laboratory variables as judged by the responsible medical officer.
Time frame: Pre-entry to follow-up

Results

Posted Aug 13, 2012

Participant flow

In total 25 participants were enrolled into the study at 2 medical centres (14 and 11 participants), 20 of them were randomised to treatment (10 at each medical centre) and all these 20 participants completed the study.

Period 1 - First Intervention

Participant flow — Period 1 - First Intervention
Milestone	First 5 mg, Then Placebo, Then 16 mg, Then 40 mg	First 40 mg, Then 16 mg, Then Placebo, Then 5 mg	First 16 mg, Then 5 mg, Then 40 mg, Then Placebo	First Placebo, Then 40 mg, Then 5 mg, Then 16 mg
Started	4	7	4	5
Completed	4	7	4	5
Not completed	0	0	0	0

Period 2 - Washout

Participant flow — Period 2 - Washout
Milestone	First 5 mg, Then Placebo, Then 16 mg, Then 40 mg	First 40 mg, Then 16 mg, Then Placebo, Then 5 mg	First 16 mg, Then 5 mg, Then 40 mg, Then Placebo	First Placebo, Then 40 mg, Then 5 mg, Then 16 mg
Started	4	7	4	5
Completed	4	7	4	5
Not completed	0	0	0	0

Period 3- Second Intervention

Participant flow — Period 3- Second Intervention
Milestone	First 5 mg, Then Placebo, Then 16 mg, Then 40 mg	First 40 mg, Then 16 mg, Then Placebo, Then 5 mg	First 16 mg, Then 5 mg, Then 40 mg, Then Placebo	First Placebo, Then 40 mg, Then 5 mg, Then 16 mg
Started	4	7	4	5
Completed	4	7	4	5
Not completed	0	0	0	0

Period 4 - Washout

Participant flow — Period 4 - Washout
Milestone	First 5 mg, Then Placebo, Then 16 mg, Then 40 mg	First 40 mg, Then 16 mg, Then Placebo, Then 5 mg	First 16 mg, Then 5 mg, Then 40 mg, Then Placebo	First Placebo, Then 40 mg, Then 5 mg, Then 16 mg
Started	4	7	4	5
Completed	4	7	4	5
Not completed	0	0	0	0

Period 5 - Third Intervention

Participant flow — Period 5 - Third Intervention
Milestone	First 5 mg, Then Placebo, Then 16 mg, Then 40 mg	First 40 mg, Then 16 mg, Then Placebo, Then 5 mg	First 16 mg, Then 5 mg, Then 40 mg, Then Placebo	First Placebo, Then 40 mg, Then 5 mg, Then 16 mg
Started	4	7	4	5
Completed	4	7	4	5
Not completed	0	0	0	0

Period 6 - Washout

Participant flow — Period 6 - Washout
Milestone	First 5 mg, Then Placebo, Then 16 mg, Then 40 mg	First 40 mg, Then 16 mg, Then Placebo, Then 5 mg	First 16 mg, Then 5 mg, Then 40 mg, Then Placebo	First Placebo, Then 40 mg, Then 5 mg, Then 16 mg
Started	4	7	4	5
Completed	4	7	4	5
Not completed	0	0	0	0

Period 7 - Fourth Intervention

Participant flow — Period 7 - Fourth Intervention
Milestone	First 5 mg, Then Placebo, Then 16 mg, Then 40 mg	First 40 mg, Then 16 mg, Then Placebo, Then 5 mg	First 16 mg, Then 5 mg, Then 40 mg, Then Placebo	First Placebo, Then 40 mg, Then 5 mg, Then 16 mg
Started	4	7	4	5
Completed	4	7	4	5
Not completed	0	0	0	0

Outcome measures

PrimaryReflux Episodes 0 to 3 Hours Post Meal

Total number of reflux episodes 0 to 3 hours post meal

Time frame:: 0 to 3 hours post meal
Reported as:: Geometric mean · Episodes

Reflux Episodes 0 to 3 Hours Post Meal
Episodes	AZD2516 5 mg	AZD2516 16 mg	AZD2516 40 mg	Placebo
Reflux Episodes 0 to 3 Hours Post Meal	15.1 (1 to 149)	12.5 (0 to 50)	11.0 (0 to 41)	12.7 (0 to 40)

SecondaryTransient Lower Esophagus Sphincter Relaxations (TLESRs) 0 to 3 Hours Post Meal

Number of TLESRs 0 to 3 hours post meal were calculated based upon the manometric analysis fpr the 3-hour post-meal period.

Time frame:: 0 to 3 hours post meal
Reported as:: Geometric mean · relaxations

Transient Lower Esophagus Sphincter Relaxations (TLESRs) 0 to 3 Hours Post Meal
relaxations	AZD2516 5 mg	AZD2516 16 mg	AZD2516 40 mg	Placebo
Transient Lower Esophagus Sphincter Relaxations (TLESRs) 0 to 3 Hours Post Meal	16.9 (8 to 51)	16.2 (9 to 26)	10.4 (2 to 31)	16.8 (9 to 33)

SecondaryArea Under the Plasma Concentration Curve(AUC)

Area under the plasma concentration vs. time curve from time zero to 12-hours post dose calculated by loglinear trapezoidal method

Time frame:: 0 to 12 hours post dose
Reported as:: Geometric mean · nmol*h/L

Area Under the Plasma Concentration Curve(AUC)
nmol*h/L	AZD2516 5 mg	AZD2516 16 mg	AZD2516 40 mg	Placebo
Area Under the Plasma Concentration Curve(AUC)	251.5 (188.4 to 335.7)	906.6 (732.7 to 1122)	2825 (2185 to 3653)	—

SecondaryAverage Plasma Concentration (C Average)

Average plasma concentration

Time frame:: 1 to 4 hours post dose
Reported as:: Geometric mean · nmol/L

Average Plasma Concentration (C Average)
nmol/L	AZD2516 5 mg	AZD2516 16 mg	AZD2516 40 mg	Placebo
Average Plasma Concentration (C Average)	45.46 (35.04 to 58.98)	175.8 (142.4 to 217.1)	506.8 (405.0 to 634.3)	—

SecondaryMaximum Plasma Concentration (Cmax)

Maximum plasma concentration

Time frame:: 0 to 12 hours post dose
Reported as:: Geometric mean · nmol/L

Maximum Plasma Concentration (Cmax)
nmol/L	AZD2516 5 mg	AZD2516 16 mg	AZD2516 40 mg	Placebo
Maximum Plasma Concentration (Cmax)	103.8 (76.09 to 141.5)	378.0 (315.0 to 453.5)	911.7 (767.3 to 1083)	—

SecondaryTime to Maximum Plasma Concentration (Tmax)

Time to maximum plasma concentration (Tmax)

Time frame:: 0 to 12 hours post dose
Reported as:: Median · hours

Time to Maximum Plasma Concentration (Tmax)
hours	AZD2516 5 mg	AZD2516 16 mg	AZD2516 40 mg	Placebo
Time to Maximum Plasma Concentration (Tmax)	0.750 (0.500 to 4.000)	0.750 (0.500 to 1.250)	1.000 (0.500 to 4.000)	—

SecondaryTerminal Half-life (T Half)

Terminal half-life (T half)

Time frame:: 0 to 12 hours post dose
Reported as:: Geometric mean · hours

Terminal Half-life (T Half)
hours	AZD2516 5 mg	AZD2516 16 mg	AZD2516 40 mg	Placebo
Terminal Half-life (T Half)	1.221 (1.042 to 1.430)	1.416 (1.222 to 1.640)	1.584 (1.414 to 1.774)	—

SecondaryClinically Relevant Change of Laboratory Variables

Number of participants with clinically relevant change of laboratory variables as judged by the responsible medical officer.

Time frame:: Pre-entry to follow-up
Reported as:: Number · Participants

Clinically Relevant Change of Laboratory Variables
Participants	AZD2516 5 mg	AZD2516 16 mg	AZD2516 40 mg	Placebo
Clinically Relevant Change of Laboratory Variables	0	0	0	0

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
AZD2516 5 mg	—	0/20 (0%)	4/20 (20%)
AZD2516 16 mg	—	0/20 (0%)	8/20 (40%)
AZD2516 40 mg	—	0/20 (0%)	12/20 (60%)
Placebo	—	0/20 (0%)	3/20 (15%)

Most frequent other events

Showing 10 of 16

Most frequent other events
Event	AZD2516 5 mg	AZD2516 16 mg	AZD2516 40 mg	Placebo
DizzinessNervous system disorders	0/20	1/20	7/20	0/20
Disturbance In AttentionNervous system disorders	2/20	5/20	4/20	0/20
HeadacheNervous system disorders	1/20	3/20	2/20	0/20
FlatulenceGastrointestinal disorders	0/20	0/20	1/20	2/20
Euphoric MoodPsychiatric disorders	0/20	2/20	2/20	0/20
Balance DisorderNervous system disorders	0/20	0/20	1/20	0/20
ParaesthesiaNervous system disorders	0/20	0/20	1/20	0/20
Sinus HeadacheNervous system disorders	1/20	0/20	0/20	0/20
SomnolenceNervous system disorders	1/20	0/20	1/20	0/20
Abdominal PainGastrointestinal disorders	0/20	0/20	1/20	0/20

Baseline characteristics

Age Continuous
Age Continuous(years)	AZD2516 5 mg	AZD2516 16 mg	AZD2516 40 mg	Placebo	Total
Age (years)	31 ± 9.6	25 ± 4.5	28.8 ± 5.9	23 ± 4.2	26.95 ± 6.3

Sex: Female, Male
Sex: Female, Male(Participants)	AZD2516 5 mg	AZD2516 16 mg	AZD2516 40 mg	Placebo	Total
Female	0	0	0	0	0
Male	4	7	4	5	20

Study locations

2 sites

Research Site
Leuven, Belgium
Research Site
Amsterdam, Netherlands

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 30, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01154634
Lead sponsor: AstraZeneca
Responsible party: Sponsor
First posted: Jul 1, 2010
Start date: May 2010
Primary completion: Sep 2010
Completion: Sep 2010
Results posted: Aug 13, 2012
Last update: Aug 30, 2012

Study contacts

Mark Berner Hansen

study director · AstraZeneca R&D Molndal

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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