Trial Outcomes & Findings for Bioavailability Study of 10 Milligram (mg) and 5 mg Tablets Versus Conventional Tablets of Dolutegravir (NCT NCT03095638)
NCT ID: NCT03095638
Last Updated: 2019-07-23
Results Overview
Blood samples were collected at the indicated time points after administration of study treatment to investigate the pharmacokinetic (PK) profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. The PK Population was defined as participants in the All Subjects Population for whom a PK sample was obtained and that had evaluable PK assay results.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
38 participants
Primary outcome timeframe
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1
Results posted on
2019-07-23
Participant Flow
This study was conducted at 1 site in the United States of America from 03 May 2017 to 23 Jun 2017. The study was conducted in 2 parts and a total of 38 participants were enrolled: 14 in Part 1 (treatment A and B over 2 dosing periods) and 24 in Part 2 (treatment C,D,E, over 3 dosing periods) with washout of 7(-4 hours) days between doses.
A total of 106 participants were screened however 68 were screen failures the reasons for which were did not meet inclusion/exclusion, adverse event, lost to follow up, investigator discretion, withdrew consent and screened but enrollment target reached prior to enrollment. All of the 38 enrolled participants completed the study.
Participant milestones
| Measure |
DTG 10 mg Followed by DTG 50 mg: Part 1
Participants in Part 1 (P1), received Five 10 milligrams (mg) Dolutegravir \[DTG\] tablets direct to mouth with 240 milliliters (mL) of water in Treatment Period 1 followed by One 50 mg DTG tablet direct to mouth with 240 mL of water in Treatment Period 2. There was a washout of 7(-4 hours) days between the treatment periods 1 and 2.
|
DTG 50 mg Followed by DTG 10 mg: Part 1
Participants in P1, received One 50 mg DTG tablet direct to mouth with 240 mL of water in Treatment Period 1 followed by Five 10 mg DTG tablets direct to mouth with 240 mL of water in Treatment Period 2. There was a washout of 7(-4 hours) days between the treatment periods 1 and 2.
|
DTG 5 mg (Test 1) Then DTG 5 mg (Test 2) Then by DTG 25 mg: P2
Participants in P2, received Dispersible 5 mg DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 1) in Treatment Period 1, followed by Dispersible 5 mg DTG tablet (5 tablets) administered as direct to mouth (test 2) in Treatment Period 2, followed by Conventional 25 mg DTG tablet administered as direct to mouth \[reference\]) in Treatment Period 3. There was a washout of 7(-4 hours) days between the treatment periods 1, 2 and 3.
|
DTG 5 mg Then DTG 25 mg (Reference) Then DTG 5 mg: Part 2
Participants in P2, received Dispersible 5 mg DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 2) in Treatment Period 1, followed by Conventional 25 mg DTG tablet administered as direct to mouth (reference) in Treatment Period 2, followed by Dispersible 5 mg DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 1) in Treatment Period 3. There was a washout of 7(-4 hours) days between the treatment periods 1, 2 and 3.
|
DTG 25 mg (Reference) DTG 5 mg Followed by DTG 5 mg: P2
Participants in P2, received Conventional 25 mg DTG tablet administered as direct to mouth (reference) in Treatment Period 1, followed by Dispersible 5 mg DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 1) in Treatment Period 2, followed by Dispersible 5 mg DTG tablet (5 tablets) administered as direct to mouth (test 2) in Treatment Period 3. There was a washout of 7(-4 hours) days between the treatment periods 1, 2 and 3.
|
DTG 5 mg Then DTG 25 mg Then DTG 5 mg: P2
Participants in P2, received Dispersible 5 mg DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 1) in Treatment Period 1, followed by Conventional 25 mg DTG tablet administered as direct to mouth (reference) in Treatment Period 2, followed by Dispersible 5 mg DTG tablet (5 tablets) administered as direct to mouth (test 2) in Treatment Period 3. There was a washout of 7(-4 hours) days between the treatment periods 1, 2 and 3.
|
DTG 5 mg Followed by DTG 5 mg Followed by DTG 25 mg: Part 2
Participants in P2, received Dispersible 5 mg DTG tablet (5 tablets) administered as direct to mouth (test 2) in Treatment Period 1, followed by (Dispersible 5 mg DTG tablet \[5 tablets\] administered as a dispersion and immediately taken (test 1) in Treatment Period 2, followed by Conventional 25 mg DTG tablet administered as direct to mouth (reference) in Treatment Period 3. There was a washout of 7(-4 hours) days between the treatment periods 1, 2 and 3.
|
DTG 25 mg Followed by DTG 5 mg Followed by DTG 5 mg: Part 2
Participants in P2, received Conventional 25 mg DTG tablet administered as direct to mouth (reference) in Treatment Period 1, followed by Dispersible 5 mg DTG tablet (5 tablets) administered as direct to mouth (test 2) in Treatment Period 2, followed by Dispersible 5 mg DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 1) in Treatment Period 3. There was a washout of 7(-4 hours) days between the treatment periods 1, 2 and 3.
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|---|---|---|---|---|---|---|---|---|
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P1: Period 1 (4 Days)
STARTED
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7
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7
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0
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0
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0
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0
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0
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0
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P1: Period 1 (4 Days)
COMPLETED
|
7
|
7
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0
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0
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0
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0
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0
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0
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P1: Period 1 (4 Days)
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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P1: Period 1, Washout (7 [-4 Hours])
STARTED
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7
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7
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0
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0
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0
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0
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0
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0
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P1: Period 1, Washout (7 [-4 Hours])
COMPLETED
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7
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7
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0
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0
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0
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0
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0
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0
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P1: Period 1, Washout (7 [-4 Hours])
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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P1: Period 2 (4 Days)
STARTED
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7
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7
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0
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0
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0
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0
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0
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0
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P1: Period 2 (4 Days)
COMPLETED
|
7
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7
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0
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0
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0
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0
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0
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0
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P1: Period 2 (4 Days)
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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P1: Period 2, Washout (7[-4 Hours])
STARTED
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7
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7
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0
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0
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0
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0
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0
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0
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P1: Period 2, Washout (7[-4 Hours])
COMPLETED
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7
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7
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0
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0
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0
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0
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0
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0
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P1: Period 2, Washout (7[-4 Hours])
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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P2: Period 1 (4 Days)
STARTED
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0
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0
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4
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4
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4
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4
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4
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4
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P2: Period 1 (4 Days)
COMPLETED
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0
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0
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4
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4
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4
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4
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4
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4
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P2: Period 1 (4 Days)
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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P2: Period 1, Washout (7[-4 Hours])
STARTED
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0
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0
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4
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4
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4
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4
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4
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4
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P2: Period 1, Washout (7[-4 Hours])
COMPLETED
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0
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0
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4
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4
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4
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4
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4
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4
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P2: Period 1, Washout (7[-4 Hours])
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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P2: Period 2 (4 Days)
STARTED
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0
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0
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4
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4
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4
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4
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4
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4
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P2: Period 2 (4 Days)
COMPLETED
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0
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0
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4
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4
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4
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4
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4
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4
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P2: Period 2 (4 Days)
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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P2: Period 2, Washout (7[-4 Hours])
STARTED
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0
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0
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4
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4
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4
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4
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4
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4
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P2: Period 2, Washout (7[-4 Hours])
COMPLETED
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0
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0
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4
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4
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4
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4
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4
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4
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P2: Period 2, Washout (7[-4 Hours])
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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P2: Period 3 (4 Days)
STARTED
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0
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0
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4
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4
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4
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4
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4
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4
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P2: Period 3 (4 Days)
COMPLETED
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0
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0
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4
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4
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4
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4
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4
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4
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P2: Period 3 (4 Days)
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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P2: Period 3, Washout (7[-4 Hours])
STARTED
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0
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0
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4
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4
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4
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4
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4
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4
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P2: Period 3, Washout (7[-4 Hours])
COMPLETED
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0
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0
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4
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4
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4
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4
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4
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4
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P2: Period 3, Washout (7[-4 Hours])
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bioavailability Study of 10 Milligram (mg) and 5 mg Tablets Versus Conventional Tablets of Dolutegravir
Baseline characteristics by cohort
| Measure |
Total Participants: Part 1
n=14 Participants
Participants in Part 1 of the study received each of 2 treatments Five 10 mg DTG tablets direct to mouth with 240 mL of water and One 50 mg DTG tablet direct to mouth with 240 mL of water over 2 Treatment periods. There was a washout of at least 7 (-4 hours) days between the Treatment Periods 1 and 2.
|
Total Participants: Part 2
n=24 Participants
Participants in Part 2, of the study received each of the 3 treatments Dispersible 5 mg DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 1), Dispersible 5 mg DTG tablet (5 tablets) administered as direct to mouth (test 1) and Conventional 25-mg DTG tablet administered as direct to mouth \[reference\]) over 3 Treatment Periods. There was a washout of 7(-4 hours) days between the treatment periods 1, 2 and 3.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.1 Years
STANDARD_DEVIATION 9.00 • n=5 Participants
|
35.7 Years
STANDARD_DEVIATION 9.71 • n=7 Participants
|
34.9 Years
STANDARD_DEVIATION 9.355 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1Population: PK Population
Blood samples were collected at the indicated time points after administration of study treatment to investigate the pharmacokinetic (PK) profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. The PK Population was defined as participants in the All Subjects Population for whom a PK sample was obtained and that had evaluable PK assay results.
Outcome measures
| Measure |
DTG 10 mg
n=14 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=14 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time of Dose Extrapolated to Infinite Time (AUC[0-infinity]) of DTG for Part 1
|
58900 hours*nanograms/mL (h*ng/mL)
Geometric Coefficient of Variation 37.2
|
58400 hours*nanograms/mL (h*ng/mL)
Geometric Coefficient of Variation 29.3
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1Population: PK Population
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times..
Outcome measures
| Measure |
DTG 10 mg
n=14 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=14 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time of Dose to Last Measurable Concentration AUC [0-t] of DTG for Part 1
|
55800 h*ng/mL
Geometric Coefficient of Variation 36.6
|
55200 h*ng/mL
Geometric Coefficient of Variation 27.3
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1Population: PK Population
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Outcome measures
| Measure |
DTG 10 mg
n=14 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=14 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of DTG for Part 1
|
2780 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 42.1
|
2700 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 25.7
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2Population: PK population
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times..
Outcome measures
| Measure |
DTG 10 mg
n=24 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=24 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
n=24 Participants
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
AUC (0-infinity) of DTG for Part 2
|
51300 h*ng/mL
Geometric Coefficient of Variation 18.8
|
48800 h*ng/mL
Geometric Coefficient of Variation 26.9
|
31600 h*ng/mL
Geometric Coefficient of Variation 34.4
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2Population: PK Population
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Outcome measures
| Measure |
DTG 10 mg
n=24 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=24 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
n=24 Participants
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
AUC (0-t) of DTG for Part 2
|
49000 h*ng/mL
Geometric Coefficient of Variation 17.5
|
46700 h*ng/mL
Geometric Coefficient of Variation 26.0
|
30100 h*ng/mL
Geometric Coefficient of Variation 33.7
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2Population: PK Population
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Outcome measures
| Measure |
DTG 10 mg
n=24 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=24 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
n=24 Participants
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Cmax of DTG for Part 2
|
2690 ng/mL
Geometric Coefficient of Variation 24.2
|
2700 ng/mL
Geometric Coefficient of Variation 31.5
|
1500 ng/mL
Geometric Coefficient of Variation 34.2
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1Population: PK Population
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Outcome measures
| Measure |
DTG 10 mg
n=14 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=14 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Plasma DTG Lag Time Before Observation of Drug Concentrations (Tlag) for Part 1
|
0.00 hours
Interval 0.0 to 0.0
|
0.00 hours
Interval 0.0 to 0.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1Population: PK Population
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Outcome measures
| Measure |
DTG 10 mg
n=14 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=14 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Time to First Occurrence of Cmax (Tmax) of DTG for Part 1
|
2.01 hours
Interval 1.0 to 6.0
|
2.00 hours
Interval 0.5 to 5.03
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1Population: PK population
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Outcome measures
| Measure |
DTG 10 mg
n=14 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=14 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Terminal Phase Half-life (t1/2) of DTG for Part 1
|
15.81 hours
Geometric Coefficient of Variation 22.7
|
16.23 hours
Geometric Coefficient of Variation 20.8
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1Population: PK Population
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Outcome measures
| Measure |
DTG 10 mg
n=14 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=14 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Terminal-phase Rate Constant (Lambda z) of DTG for Part 1
|
0.0439 per hour
Geometric Coefficient of Variation 22.7
|
0.0427 per hour
Geometric Coefficient of Variation 20.8
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1Population: PK Population
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Outcome measures
| Measure |
DTG 10 mg
n=14 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=14 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Percentage of AUC (0-infinity) Obtained by Extrapolation (%AUCex) of DTG for Part 1
|
5.17 Percentage of AUC
Interval 2.96 to 7.38
|
5.52 Percentage of AUC
Interval 3.43 to 7.61
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1Population: PK Population
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Outcome measures
| Measure |
DTG 10 mg
n=14 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=14 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Area Under the Concentration-time Curve Over Time Zero (Pre-dose) to 24 Hours After Dose Administration (AUC[0-24]) of DTG for Part 1
|
37500 h*ng/mL
Geometric Coefficient of Variation 38.1
|
36600 h*ng/mL
Geometric Coefficient of Variation 24.3
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1Population: PK Population
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times..
Outcome measures
| Measure |
DTG 10 mg
n=14 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=14 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Apparent Oral Clearance (CL/F) of DTG for Part 1
|
0.849 Liters/hour
Geometric Coefficient of Variation 37.2
|
0.856 Liters/hour
Geometric Coefficient of Variation 29.3
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1Population: PK Population
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Outcome measures
| Measure |
DTG 10 mg
n=14 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=14 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Apparent Volume of Distribution During the Terminal Phase (Vz/F) of DTG for Part 1
|
19.4 Liters
Geometric Coefficient of Variation 39.2
|
20.0 Liters
Geometric Coefficient of Variation 22.8
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1Population: PK Population
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Outcome measures
| Measure |
DTG 10 mg
n=14 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=14 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Last Observed Quantifiable Concentration (Ct) of DTG for Part 1
|
106 ng/mL
Geometric Coefficient of Variation 72.8
|
114 ng/mL
Geometric Coefficient of Variation 73.5
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1Population: PK Population
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Outcome measures
| Measure |
DTG 10 mg
n=14 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=14 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Observed Concentration at 24 Hours After Dose Administration (C24) of DTG for Part 1
|
912 ng/mL
Geometric Coefficient of Variation 37.2
|
916 ng/mL
Geometric Coefficient of Variation 29.4
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2Population: PK Population
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Outcome measures
| Measure |
DTG 10 mg
n=24 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=24 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
n=24 Participants
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Plasma DTG Tlag for Part 2
|
0.00 hours
Interval 0.0 to 0.0
|
0.00 hours
Interval 0.0 to 0.0
|
0.00 hours
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2Population: PK Population
Blood sample were collected at the indicated time points after administration of study treatment to investigate the pharmacokinetic profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Outcome measures
| Measure |
DTG 10 mg
n=24 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=24 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
n=24 Participants
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Tmax of DTG for Part 2
|
1.00 hours
Interval 0.5 to 6.0
|
1.00 hours
Interval 0.5 to 5.0
|
1.75 hours
Interval 0.5 to 4.0
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2Population: PK Population
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Outcome measures
| Measure |
DTG 10 mg
n=24 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=24 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
n=24 Participants
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
t1/2 of DTG for Part 2
|
15.66 hours
Geometric Coefficient of Variation 15.3
|
15.48 hours
Geometric Coefficient of Variation 14.3
|
15.78 hours
Geometric Coefficient of Variation 14.7
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2Population: PK Population
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times
Outcome measures
| Measure |
DTG 10 mg
n=24 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=24 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
n=24 Participants
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Lambda Z of DTG for Part 2
|
0.0443 per hour
Geometric Coefficient of Variation 15.3
|
0.0448 per hour
Geometric Coefficient of Variation 14.3
|
0.0439 per hour
Geometric Coefficient of Variation 14.7
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2Population: PK Population
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Outcome measures
| Measure |
DTG 10 mg
n=24 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=24 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
n=24 Participants
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
%AUCex of DTG for Part 2
|
4.37 Percentage of AUC
Interval 3.39 to 5.35
|
4.23 Percentage of AUC
Interval 3.35 to 5.11
|
4.66 Percentage of AUC
Interval 3.61 to 5.71
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2Population: PK Population
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Outcome measures
| Measure |
DTG 10 mg
n=24 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=24 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
n=24 Participants
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
AUC (0-24) of DTG for Part 2
|
34000 h*ng/mL
Geometric Coefficient of Variation 16.1
|
32300 h*ng/mL
Geometric Coefficient of Variation 24.9
|
20400 h*ng/mL
Geometric Coefficient of Variation 32.7
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2Population: PK Population
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Outcome measures
| Measure |
DTG 10 mg
n=24 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=24 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
n=24 Participants
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
DTG CL/F for Part 2
|
0.487 Liters/hour
Geometric Coefficient of Variation 18.8
|
0.513 Liters/hour
Geometric Coefficient of Variation 26.9
|
0.792 Liters/hour
Geometric Coefficient of Variation 34.4
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2Population: PK Population
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Outcome measures
| Measure |
DTG 10 mg
n=24 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=24 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
n=24 Participants
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Vz/F of DTG for Part 2
|
11.0 Liters
Geometric Coefficient of Variation 15.8
|
11.4 Liters
Geometric Coefficient of Variation 24.6
|
18.0 Liters
Geometric Coefficient of Variation 33.5
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2Population: PK Population
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times
Outcome measures
| Measure |
DTG 10 mg
n=24 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=24 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
n=24 Participants
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Ct of DTG for Part 2
|
89.3 ng/mL
Geometric Coefficient of Variation 45.7
|
84.4 ng/mL
Geometric Coefficient of Variation 48.0
|
58.2 ng/mL
Geometric Coefficient of Variation 54.7
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2Population: PK Population
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Outcome measures
| Measure |
DTG 10 mg
n=24 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=24 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
n=24 Participants
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
C24 of DTG for Part 2
|
770 ng/mL
Geometric Coefficient of Variation 19.0
|
741 ng/mL
Geometric Coefficient of Variation 26.9
|
493 ng/mL
Geometric Coefficient of Variation 36.0
|
SECONDARY outcome
Timeframe: Up to 25 days in Part 1Population: All Subjects Population
AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Data has been presented for AEs and SAEs up-to follow-up (25 days) in Part 1. All Subjects Population was defined as all participants who received at least 1 dose of study medication.
Outcome measures
| Measure |
DTG 10 mg
n=14 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=14 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) for Part 1
Any AE
|
1 Participants
|
2 Participants
|
—
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) for Part 1
Any SAE
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 36 days in Part 2Population: All Subjects Population
AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Data has been presented for AEs and SAEs up-to follow-up (36 days) in Part 2.
Outcome measures
| Measure |
DTG 10 mg
n=24 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=24 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
n=24 Participants
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Number of Participants With Adverse Events AEs and Serious Adverse Events SAEs for Part 2
Any AE
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events AEs and Serious Adverse Events SAEs for Part 2
Any SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and up to 25 days in Part 1Population: All Subjects Population
Blood samples for the assessment of chemistry parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for serum glucose, serum calcium, serum potassium, serum sodium, serum urea results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Outcome measures
| Measure |
DTG 10 mg
n=14 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=14 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Change From Baseline in Clinical Laboratory Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 1
Serum glucose, Day 2, n=14, 14
|
-0.091 millimoles/liter (mmol/L)
Standard Deviation 0.2796
|
0.071 millimoles/liter (mmol/L)
Standard Deviation 0.2641
|
—
|
|
Change From Baseline in Clinical Laboratory Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 1
Serum glucose, Follow-up, n=5, 5
|
-0.178 millimoles/liter (mmol/L)
Standard Deviation 0.5554
|
0.022 millimoles/liter (mmol/L)
Standard Deviation 0.4315
|
—
|
|
Change From Baseline in Clinical Laboratory Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 1
Serum calcium, Day 2, n=14, 14
|
0.001 millimoles/liter (mmol/L)
Standard Deviation 0.0679
|
-0.005 millimoles/liter (mmol/L)
Standard Deviation 0.0682
|
—
|
|
Change From Baseline in Clinical Laboratory Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 1
Serum calcium, Follow-up, n=5, 5
|
-0.024 millimoles/liter (mmol/L)
Standard Deviation 0.0764
|
-0.044 millimoles/liter (mmol/L)
Standard Deviation 0.0537
|
—
|
|
Change From Baseline in Clinical Laboratory Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 1
Serum Potassium, Day 2, n=14, 14
|
0.08 millimoles/liter (mmol/L)
Standard Deviation 0.258
|
0.09 millimoles/liter (mmol/L)
Standard Deviation 0.300
|
—
|
|
Change From Baseline in Clinical Laboratory Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 1
Serum Potassium, Follow-up, n=5, 5
|
-0.26 millimoles/liter (mmol/L)
Standard Deviation 0.182
|
-0.26 millimoles/liter (mmol/L)
Standard Deviation 0.207
|
—
|
|
Change From Baseline in Clinical Laboratory Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 1
Serum Sodium, Day 2, n=14, 14
|
-1.3 millimoles/liter (mmol/L)
Standard Deviation 2.20
|
-0.7 millimoles/liter (mmol/L)
Standard Deviation 2.23
|
—
|
|
Change From Baseline in Clinical Laboratory Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 1
Serum Sodium, Follow-up, n=5, 5
|
-1.6 millimoles/liter (mmol/L)
Standard Deviation 1.14
|
-0.6 millimoles/liter (mmol/L)
Standard Deviation 1.82
|
—
|
|
Change From Baseline in Clinical Laboratory Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 1
Serum Urea, Day 2, n=14, 14
|
-0.394 millimoles/liter (mmol/L)
Standard Deviation 1.2216
|
-0.444 millimoles/liter (mmol/L)
Standard Deviation 1.1499
|
—
|
|
Change From Baseline in Clinical Laboratory Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 1
Serum Urea, Follow-up, n=5, 5
|
0.248 millimoles/liter (mmol/L)
Standard Deviation 1.6064
|
-0.248 millimoles/liter (mmol/L)
Standard Deviation 1.6173
|
—
|
SECONDARY outcome
Timeframe: Baseline and up to 25 days in Part 1Population: All Subjects Population
Blood samples for the assessment of chemistry parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for serum ALT, serum alkaline phosphatase, serum AST, serum creatine kinase results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Outcome measures
| Measure |
DTG 10 mg
n=14 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=14 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters Serum Alanine Amino Transferase (ALT), Serum Alkaline Phosphatase, Serum Aspartate Amino Transferase (AST), Serum Creatine Kinase for Part 1
Serum ALT, Day 2, n=14, 14
|
0.8 International units/liter (IU/L)
Standard Deviation 6.29
|
-1.1 International units/liter (IU/L)
Standard Deviation 2.18
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters Serum Alanine Amino Transferase (ALT), Serum Alkaline Phosphatase, Serum Aspartate Amino Transferase (AST), Serum Creatine Kinase for Part 1
Serum ALT, Follow-up, n=5, 5
|
-1.6 International units/liter (IU/L)
Standard Deviation 3.58
|
-1.0 International units/liter (IU/L)
Standard Deviation 2.00
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters Serum Alanine Amino Transferase (ALT), Serum Alkaline Phosphatase, Serum Aspartate Amino Transferase (AST), Serum Creatine Kinase for Part 1
Serum alkaline phosphatase, Day 2, n=14, 14
|
1.5 International units/liter (IU/L)
Standard Deviation 3.98
|
0.8 International units/liter (IU/L)
Standard Deviation 3.12
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters Serum Alanine Amino Transferase (ALT), Serum Alkaline Phosphatase, Serum Aspartate Amino Transferase (AST), Serum Creatine Kinase for Part 1
Serum alkaline phosphatase, Follow-up, n=5, 5
|
1.4 International units/liter (IU/L)
Standard Deviation 2.19
|
1.0 International units/liter (IU/L)
Standard Deviation 5.00
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters Serum Alanine Amino Transferase (ALT), Serum Alkaline Phosphatase, Serum Aspartate Amino Transferase (AST), Serum Creatine Kinase for Part 1
Serum AST, Day 2, n=14, 14
|
0.6 International units/liter (IU/L)
Standard Deviation 4.88
|
-0.9 International units/liter (IU/L)
Standard Deviation 1.29
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters Serum Alanine Amino Transferase (ALT), Serum Alkaline Phosphatase, Serum Aspartate Amino Transferase (AST), Serum Creatine Kinase for Part 1
Serum creatine kinase, Day 2, n=14, 14
|
-43.6 International units/liter (IU/L)
Standard Deviation 64.32
|
-37.1 International units/liter (IU/L)
Standard Deviation 52.19
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters Serum Alanine Amino Transferase (ALT), Serum Alkaline Phosphatase, Serum Aspartate Amino Transferase (AST), Serum Creatine Kinase for Part 1
Serum creatine kinase, Follow-up, n=5, 5
|
-17.2 International units/liter (IU/L)
Standard Deviation 33.21
|
0.8 International units/liter (IU/L)
Standard Deviation 22.75
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters Serum Alanine Amino Transferase (ALT), Serum Alkaline Phosphatase, Serum Aspartate Amino Transferase (AST), Serum Creatine Kinase for Part 1
Serum AST, Follow-up, n=5, 5
|
-1.0 International units/liter (IU/L)
Standard Deviation 3.32
|
0.6 International units/liter (IU/L)
Standard Deviation 0.89
|
—
|
SECONDARY outcome
Timeframe: Baseline and up to 25 days in Part 1Population: All Subjects Population
Blood samples for the assessment of chemistry parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for serum albumin and serum protein results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Outcome measures
| Measure |
DTG 10 mg
n=14 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=14 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1
Serum Protein, Follow-up, n=5, 5
|
0.8 Grams/liter (g/L)
Standard Deviation 1.79
|
1.8 Grams/liter (g/L)
Standard Deviation 3.27
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1
Serum Albumin, Day 2, n=14, 14
|
0.3 Grams/liter (g/L)
Standard Deviation 1.94
|
0.1 Grams/liter (g/L)
Standard Deviation 1.79
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1
Serum Albumin, Follow-up, n=5, 5
|
-1.2 Grams/liter (g/L)
Standard Deviation 1.30
|
-0.4 Grams/liter (g/L)
Standard Deviation 1.82
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1
Serum Protein, Day 2, n=14, 14
|
2.3 Grams/liter (g/L)
Standard Deviation 3.83
|
2.4 Grams/liter (g/L)
Standard Deviation 3.76
|
—
|
SECONDARY outcome
Timeframe: Baseline and up to 25 days in Part 1Population: All Subjects Population
Blood samples for the assessment of chemistry parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for serum bilirubin, serum creatinine and serum direct bilirubin results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Outcome measures
| Measure |
DTG 10 mg
n=14 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=14 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1
Serum Bilirubin, Day 2, n=14, 14
|
3.29 micromoles/liter (umol/L)
Standard Deviation 3.673
|
3.28 micromoles/liter (umol/L)
Standard Deviation 3.005
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1
Serum Bilirubin, Follow-u, n=5, 5
|
0.10 micromoles/liter (umol/L)
Standard Deviation 0.977
|
2.16 micromoles/liter (umol/L)
Standard Deviation 3.109
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1
Serum Creatinine, Day 2, n=14, 14
|
9.91 micromoles/liter (umol/L)
Standard Deviation 5.791
|
11.19 micromoles/liter (umol/L)
Standard Deviation 3.522
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1
Serum Creatinine, Follow-u, n=5, 5
|
4.58 micromoles/liter (umol/L)
Standard Deviation 4.289
|
3.18 micromoles/liter (umol/L)
Standard Deviation 4.164
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1
Serum direct bilirubin, Day 2, n=14, 14
|
0.24 micromoles/liter (umol/L)
Standard Deviation 0.503
|
0.30 micromoles/liter (umol/L)
Standard Deviation 0.342
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1
Serum direct bilirubin, Follow-up, n=5,5
|
0.10 micromoles/liter (umol/L)
Standard Deviation 0.141
|
0.44 micromoles/liter (umol/L)
Standard Deviation 0.428
|
—
|
SECONDARY outcome
Timeframe: Baseline and up to 36 days in Part 2Population: All Subjects Population
Blood samples for the assessment of chemistry parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for serum glucose, serum calcium, serum potassium, serum sodium, serum urea results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Outcome measures
| Measure |
DTG 10 mg
n=24 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=24 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
n=24 Participants
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2
Serum Glucose, Follow-up, n=3, 2, 3
|
0.130 mmol/L
Standard Deviation 0.2506
|
-0.060 mmol/L
Standard Deviation 0.1556
|
-0.150 mmol/L
Standard Deviation 0.1559
|
|
Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2
Serum Calcium, Day 2, n=24, 24, 24
|
0.008 mmol/L
Standard Deviation 0.0908
|
0.056 mmol/L
Standard Deviation 0.0901
|
0.036 mmol/L
Standard Deviation 0.0827
|
|
Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2
Serum Calcium, Follow-up, n=3, 2, 3
|
0.087 mmol/L
Standard Deviation 0.0603
|
-0.035 mmol/L
Standard Deviation 0.0919
|
-0.010 mmol/L
Standard Deviation 0.0529
|
|
Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2
Serum Sodium, Day 2, n=24, 24, 24
|
-0.3 mmol/L
Standard Deviation 2.37
|
0.2 mmol/L
Standard Deviation 2.02
|
-0.4 mmol/L
Standard Deviation 2.62
|
|
Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2
Serum Glucose, Day 2, n=24, 24, 24
|
-0.220 mmol/L
Standard Deviation 0.3653
|
-0.223 mmol/L
Standard Deviation 0.2715
|
-0.187 mmol/L
Standard Deviation 0.3599
|
|
Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2
Serum Potassium, Day 2, n=24, 24, 24
|
0.00 mmol/L
Standard Deviation 0.277
|
0.04 mmol/L
Standard Deviation 0.298
|
0.19 mmol/L
Standard Deviation 0.292
|
|
Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2
Serum Potassium, Follow-up, n=3, 2, 3
|
-0.03 mmol/L
Standard Deviation 0.208
|
0.05 mmol/L
Standard Deviation 0.212
|
-0.27 mmol/L
Standard Deviation 0.208
|
|
Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2
Serum Sodium, Follow-up, n=3, 2, 3
|
1.3 mmol/L
Standard Deviation 2.89
|
0.5 mmol/L
Standard Deviation 0.71
|
0.0 mmol/L
Standard Deviation 3.46
|
|
Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2
Serum Urea, Day 2, n=24, 24, 24
|
-0.868 mmol/L
Standard Deviation 1.3581
|
-0.366 mmol/L
Standard Deviation 0.8349
|
-0.376 mmol/L
Standard Deviation 1.1319
|
|
Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2
Serum Urea, Follow-up, n=3, 2, 3
|
0.067 mmol/L
Standard Deviation 1.5150
|
-0.585 mmol/L
Standard Deviation 1.2374
|
-1.237 mmol/L
Standard Deviation 0.6561
|
SECONDARY outcome
Timeframe: Baseline and up to 36 days in Part 2Population: All Subjects Population
Blood samples for the assessment of chemistry parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for serum ALT, serum alkaline phosphatase, serum AST, serum creatine kinase results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Outcome measures
| Measure |
DTG 10 mg
n=24 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=24 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
n=24 Participants
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum Alkaline Phosphate, Serum AST, Serum Creatine Kinase for Part 2
Serum ALT, Day 2, n=24, 24, 24
|
-0.4 IU/L
Standard Deviation 1.72
|
-1.0 IU/L
Standard Deviation 2.07
|
-1.1 IU/L
Standard Deviation 1.57
|
|
Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum Alkaline Phosphate, Serum AST, Serum Creatine Kinase for Part 2
Serum ALT, Follow-up, n=3, 2, 3
|
2.0 IU/L
Standard Deviation 1.73
|
-1.0 IU/L
Standard Deviation 1.41
|
0.3 IU/L
Standard Deviation 2.08
|
|
Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum Alkaline Phosphate, Serum AST, Serum Creatine Kinase for Part 2
Serum AST, Day 2, n=24, 24, 24
|
-1.4 IU/L
Standard Deviation 2.72
|
-0.7 IU/L
Standard Deviation 1.99
|
-1.3 IU/L
Standard Deviation 1.66
|
|
Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum Alkaline Phosphate, Serum AST, Serum Creatine Kinase for Part 2
Serum AST, Follow-up, n=3, 2, 3
|
0.0 IU/L
Standard Deviation 1.00
|
-3.0 IU/L
Standard Deviation 1.41
|
-0.3 IU/L
Standard Deviation 3.21
|
|
Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum Alkaline Phosphate, Serum AST, Serum Creatine Kinase for Part 2
Serum alkaline phosphatase, Day 2, n=24, 24, 24
|
0.5 IU/L
Standard Deviation 3.39
|
1.8 IU/L
Standard Deviation 3.98
|
0.2 IU/L
Standard Deviation 5.10
|
|
Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum Alkaline Phosphate, Serum AST, Serum Creatine Kinase for Part 2
Serum alkaline phosphatase, Follow-up, n=3, 2, 3
|
4.3 IU/L
Standard Deviation 2.52
|
1.0 IU/L
Standard Deviation 11.31
|
2.3 IU/L
Standard Deviation 3.51
|
|
Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum Alkaline Phosphate, Serum AST, Serum Creatine Kinase for Part 2
Serum Creatine kinase, Day 2, n=24, 24, 24
|
-35.2 IU/L
Standard Deviation 67.19
|
-15.7 IU/L
Standard Deviation 37.79
|
-37.2 IU/L
Standard Deviation 42.81
|
|
Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum Alkaline Phosphate, Serum AST, Serum Creatine Kinase for Part 2
Serum Creatine kinase, Follow-up, n=3, 2, 3
|
-7.3 IU/L
Standard Deviation 18.04
|
-10.5 IU/L
Standard Deviation 9.19
|
23.3 IU/L
Standard Deviation 43.25
|
SECONDARY outcome
Timeframe: Baseline and up to 36 days in Part 2Population: All Subjects Population
Blood samples for the assessment of chemistry parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for serum albumin and serum protein results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Outcome measures
| Measure |
DTG 10 mg
n=24 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=24 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
n=24 Participants
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 2
Serum Albumin, Day 2, n=24, 24, 24
|
0.4 g/L
Standard Deviation 2.22
|
1.1 g/L
Standard Deviation 2.24
|
0.5 g/L
Standard Deviation 2.47
|
|
Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 2
Serum Albumin, Follow-up, n=3, 2, 3
|
2.0 g/L
Standard Deviation 1.73
|
-1.0 g/L
Standard Deviation 4.24
|
1.7 g/L
Standard Deviation 0.58
|
|
Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 2
Serum Protein, Day 2, n=24, 24, 24
|
2.3 g/L
Standard Deviation 3.29
|
3.2 g/L
Standard Deviation 3.48
|
2.7 g/L
Standard Deviation 3.83
|
|
Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 2
Serum Protein, Follow-up, n=3, 2, 3
|
1.7 g/L
Standard Deviation 3.06
|
-4.0 g/L
Standard Deviation 7.07
|
0.3 g/L
Standard Deviation 1.15
|
SECONDARY outcome
Timeframe: Baseline and up to 36 days in Part 2Population: All Subjects Population
Blood samples for the assessment of chemistry parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for serum bilirubin, serum creatine and serum direct bilirubin results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Outcome measures
| Measure |
DTG 10 mg
n=24 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=24 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
n=24 Participants
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatine and Serum Direct Bilirubin for Part 2
Serum Bilirubin, Follow-u, n=3, 2, 3
|
0.97 umol/L
Standard Deviation 1.553
|
-0.80 umol/L
Standard Deviation 1.414
|
3.07 umol/L
Standard Deviation 3.612
|
|
Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatine and Serum Direct Bilirubin for Part 2
Serum Creatinine, Day 2, n=24, 24, 24
|
8.02 umol/L
Standard Deviation 4.817
|
9.83 umol/L
Standard Deviation 4.184
|
8.31 umol/L
Standard Deviation 4.218
|
|
Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatine and Serum Direct Bilirubin for Part 2
Serum Bilirubin, Day 2, n=24, 24, 24
|
2.26 umol/L
Standard Deviation 2.26
|
2.85 umol/L
Standard Deviation 2.140
|
2.91 umol/L
Standard Deviation 2.835
|
|
Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatine and Serum Direct Bilirubin for Part 2
Serum Creatinine, Follow-u, n=3, 2, 3
|
2.33 umol/L
Standard Deviation 3.293
|
-4.80 umol/L
Standard Deviation 1.838
|
-5.00 umol/L
Standard Deviation 6.539
|
|
Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatine and Serum Direct Bilirubin for Part 2
Serum direct bilirubin, Day 2, n=24, 24, 24
|
0.33 umol/L
Standard Deviation 0.464
|
0.26 umol/L
Standard Deviation 0.388
|
0.36 umol/L
Standard Deviation 0.526
|
|
Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatine and Serum Direct Bilirubin for Part 2
Serum direct bilirubin, Follow-up, n=3, 2, 3
|
-0.07 umol/L
Standard Deviation 0.153
|
-0.45 umol/L
Standard Deviation 0.354
|
0.30 umol/L
Standard Deviation 0.529
|
SECONDARY outcome
Timeframe: Baseline and up to 25 days in Part 1Population: All Subjects Population
Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood erythrocyte MCH results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Outcome measures
| Measure |
DTG 10 mg
n=14 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=14 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Change From Baseline in Hematology Parameter Blood Erythrocyte Mean Corpuscular Hemoglobin (MCH) for Part 1
Blood erythrocyte MCH, Follow-up, n=5, 5
|
0.00 Picograms (pg)
Standard Deviation 0.292
|
-0.22 Picograms (pg)
Standard Deviation 0.286
|
—
|
|
Change From Baseline in Hematology Parameter Blood Erythrocyte Mean Corpuscular Hemoglobin (MCH) for Part 1
Blood erythrocyte MCH, Day 2, n=14, 14
|
0.08 Picograms (pg)
Standard Deviation 0.426
|
-0.02 Picograms (pg)
Standard Deviation 0.283
|
—
|
SECONDARY outcome
Timeframe: Baseline and up to 25 days in Part 1Population: All Subjects Population
Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood erythrocyte MCV results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x,x in the category titles).
Outcome measures
| Measure |
DTG 10 mg
n=14 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=14 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Change From Baseline in Hematology Parameter Blood Erythrocyte Mean Corpuscular Volume (MCV) for Part 1
Blood erythrocyte MCV, Day 2, n=14, 14
|
-0.01 Femtoliters (fL)
Standard Deviation 0.598
|
0.26 Femtoliters (fL)
Standard Deviation 0.418
|
—
|
|
Change From Baseline in Hematology Parameter Blood Erythrocyte Mean Corpuscular Volume (MCV) for Part 1
Blood erythrocyte MCV, Follow-up, n=5,5
|
-0.38 Femtoliters (fL)
Standard Deviation 0.277
|
0.26 Femtoliters (fL)
Standard Deviation 0.416
|
—
|
SECONDARY outcome
Timeframe: Baseline and up to 25 days in Part 1Population: All Subjects Population
Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood basophils, blood eosinophils, blood leukocytes, blood lymphocytes, blood monocytes, blood neutrophils, blood platelets results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x,x in the category titles)
Outcome measures
| Measure |
DTG 10 mg
n=14 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=14 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1
Blood eosinophils, Follow-up, n=5, 5
|
-0.002 10^9 cells/Liter
Standard Deviation 0.0164
|
-0.072 10^9 cells/Liter
Standard Deviation 0.1666
|
—
|
|
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1
Blood leukocytes, Day 2, n=14, 14
|
-0.33 10^9 cells/Liter
Standard Deviation 0.574
|
-0.54 10^9 cells/Liter
Standard Deviation 0.633
|
—
|
|
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1
Blood leukocytes, Follow-up, n=5, 5
|
-0.06 10^9 cells/Liter
Standard Deviation 0.853
|
-0.26 10^9 cells/Liter
Standard Deviation 0.631
|
—
|
|
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1
Blood monocytes, Day 2, n=14, 14
|
-0.031 10^9 cells/Liter
Standard Deviation 0.0611
|
-0.064 10^9 cells/Liter
Standard Deviation 0.0773
|
—
|
|
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1
Blood monocytes, Follow-up, n=5, 5
|
-0.036 10^9 cells/Liter
Standard Deviation 0.0740
|
-0.040 10^9 cells/Liter
Standard Deviation 0.1279
|
—
|
|
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1
Blood neutrophils, Day 2, n=14, 14
|
-0.317 10^9 cells/Liter
Standard Deviation 0.3704
|
-0.486 10^9 cells/Liter
Standard Deviation 0.4733
|
—
|
|
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1
Blood platelets, Follow-up, n=5, 5
|
-11.2 10^9 cells/Liter
Standard Deviation 11.12
|
11.0 10^9 cells/Liter
Standard Deviation 29.56
|
—
|
|
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1
Blood basophils, Day 2, n=14, 14
|
-0.004 10^9 cells/Liter
Standard Deviation 0.0101
|
-0.013 10^9 cells/Liter
Standard Deviation 0.0230
|
—
|
|
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1
Blood basophils, Follow-up, n=5, 5
|
-0.004 10^9 cells/Liter
Standard Deviation 0.0195
|
-0.004 10^9 cells/Liter
Standard Deviation 0.0230
|
—
|
|
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1
Blood eosinophils, Day 2, n=14, 14
|
0.003 10^9 cells/Liter
Standard Deviation 0.0324
|
-0.014 10^9 cells/Liter
Standard Deviation 0.0527
|
—
|
|
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1
Blood lymphocytes, Day 2, n=14, 14
|
0.018 10^9 cells/Liter
Standard Deviation 0.2404
|
0.049 10^9 cells/Liter
Standard Deviation 0.5629
|
—
|
|
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1
Blood lymphocytes, Follow-up, n=5, 5
|
0.022 10^9 cells/Liter
Standard Deviation 0.1894
|
0.130 10^9 cells/Liter
Standard Deviation 0.4077
|
—
|
|
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1
Blood neutrophils, Follow-up, n=5, 5
|
-0.062 10^9 cells/Liter
Standard Deviation 0.6518
|
-0.264 10^9 cells/Liter
Standard Deviation 0.3824
|
—
|
|
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1
Blood platelets, Day 2, n=14, 14
|
14.0 10^9 cells/Liter
Standard Deviation 15.56
|
12.6 10^9 cells/Liter
Standard Deviation 18.21
|
—
|
SECONDARY outcome
Timeframe: Baseline and up to 25 days in Part 1Population: All Subjects Population
Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood hemoglobin results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x,x in the category titles)
Outcome measures
| Measure |
DTG 10 mg
n=14 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=14 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Change From Baseline in Hematology Parameter Blood Hemoglobin for Part 1
Blood hemoglobin, Day 2, n=14, 14
|
4.9 g/L
Standard Deviation 4.36
|
4.0 g/L
Standard Deviation 5.14
|
—
|
|
Change From Baseline in Hematology Parameter Blood Hemoglobin for Part 1
Blood hemoglobin, Follow-up, n=5, 5
|
-0.8 g/L
Standard Deviation 5.50
|
-3.4 g/L
Standard Deviation 5.98
|
—
|
SECONDARY outcome
Timeframe: Baseline and up to 25 days in Part 1Population: All Subjects Population
Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood hematocrit results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x,x in the category titles).
Outcome measures
| Measure |
DTG 10 mg
n=14 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=14 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Change From Baseline in Hematology Parameter Blood Hematocrit for Part 1
Blood hematocrit, Day 2, n=14, 14
|
0.0137 Proportion of red blood cells in blood
Standard Deviation 0.01585
|
0.0131 Proportion of red blood cells in blood
Standard Deviation 0.01353
|
—
|
|
Change From Baseline in Hematology Parameter Blood Hematocrit for Part 1
Blood hematocrit, Follow-up, n=5, 5
|
-0.0042 Proportion of red blood cells in blood
Standard Deviation 0.01462
|
-0.0058 Proportion of red blood cells in blood
Standard Deviation 0.01878
|
—
|
SECONDARY outcome
Timeframe: Baseline and up to 25 days in Part 1Population: All Subjects Population
Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood erythrocyte results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x,x in the category titles).
Outcome measures
| Measure |
DTG 10 mg
n=14 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=14 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Change From Baseline in Hematology Parameter Blood Erythrocytes for Part 1
Blood erythrocytes, Day 2, n=14, 14
|
0.182 10^12 cells/Liter
Standard Deviation 0.1679
|
0.193 10^12 cells/Liter
Standard Deviation 0.1616
|
—
|
|
Change From Baseline in Hematology Parameter Blood Erythrocytes for Part 1
Blood erythrocyte, Follow-up, n=5, 5
|
-0.024 10^12 cells/Liter
Standard Deviation 0.1638
|
-0.014 10^12 cells/Liter
Standard Deviation 0.2812
|
—
|
SECONDARY outcome
Timeframe: Baseline and up to 36 days in Part 2Population: All Subjects Population
Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood erythrocyte MCH results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x,x,x in the category titles).
Outcome measures
| Measure |
DTG 10 mg
n=24 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=24 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
n=24 Participants
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Change From Baseline in Hematology Parameter Blood Erythrocyte MCH for Part 2
Blood erythrocyte MCH, Day 2, n=24, 24, 24
|
0.12 pg
Standard Deviation 0.300
|
0.05 pg
Standard Deviation 0.292
|
0.05 pg
Standard Deviation 0.260
|
|
Change From Baseline in Hematology Parameter Blood Erythrocyte MCH for Part 2
Blood erythrocyte MCH, Follow-up, n=3, 2, 3
|
0.03 pg
Standard Deviation 0.451
|
-0.25 pg
Standard Deviation 0.212
|
0.03 pg
Standard Deviation 0.252
|
SECONDARY outcome
Timeframe: Baseline and up to 36 days in Part 2Population: All Subjects Population
Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood erythrocyte MCV results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x,x,x in the category titles).
Outcome measures
| Measure |
DTG 10 mg
n=24 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=24 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
n=24 Participants
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Change From Baseline in Hematology Parameter Blood Erythrocyte MCV for Part 2
Blood erythrocyte MCV, Day 2, n=24, 24, 24
|
-0.03 fL
Standard Deviation 0.766
|
-0.13 fL
Standard Deviation 0.761
|
0.29 fL
Standard Deviation 0.729
|
|
Change From Baseline in Hematology Parameter Blood Erythrocyte MCV for Part 2
Blood erythrocyte MCV, Follow-up, n=3, 2, 3
|
0.07 fL
Standard Deviation 1.069
|
-0.25 fL
Standard Deviation 0.212
|
-0.20 fL
Standard Deviation 0.100
|
SECONDARY outcome
Timeframe: Baseline and up to 36 days in Part 2Population: All Subjects Population
Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood basophils, blood eosinophils, blood leukocytes, blood lymphocytes, blood monocytes, blood neutrophils, blood platelets results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x,x,x in the category titles)
Outcome measures
| Measure |
DTG 10 mg
n=24 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=24 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
n=24 Participants
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2
Blood leukocytes, Follow-up, n=3, 2, 3
|
-0.63 10^9 cells/Liter
Standard Deviation 1.823
|
-2.05 10^9 cells/Liter
Standard Deviation 0.636
|
-0.23 10^9 cells/Liter
Standard Deviation 0.643
|
|
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2
Blood lymphocytes, Day 2, n=24, 24, 24
|
-0.057 10^9 cells/Liter
Standard Deviation 0.2571
|
-0.105 10^9 cells/Liter
Standard Deviation 0.3268
|
-0.196 10^9 cells/Liter
Standard Deviation 0.3254
|
|
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2
Blood lymphocytes, Follow-up, n=3, 2, 3
|
-0.130 10^9 cells/Liter
Standard Deviation 0.5603
|
0.245 10^9 cells/Liter
Standard Deviation 0.2616
|
0.293 10^9 cells/Liter
Standard Deviation 0.2919
|
|
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2
Blood basophils, Day 2, n=24, 24, 24
|
-0.004 10^9 cells/Liter
Standard Deviation 0.0088
|
-0.005 10^9 cells/Liter
Standard Deviation 0.0128
|
-0.004 10^9 cells/Liter
Standard Deviation 0.0166
|
|
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2
Blood basophils, Follow-up, n=3, 2, 3
|
0.003 10^9 cells/Liter
Standard Deviation 0.0058
|
0.000 10^9 cells/Liter
Standard Deviation 0.000
|
0.000 10^9 cells/Liter
Standard Deviation 0.0100
|
|
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2
Blood eosinophils, Day 2, n=24, 24, 24
|
-0.028 10^9 cells/Liter
Standard Deviation 0.0478
|
-0.024 10^9 cells/Liter
Standard Deviation 0.0460
|
-0.019 10^9 cells/Liter
Standard Deviation 0.0482
|
|
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2
Blood monocytes, Day 2, n=24, 24, 24
|
-0.085 10^9 cells/Liter
Standard Deviation 0.0860
|
-0.084 10^9 cells/Liter
Standard Deviation 0.0941
|
-0.104 10^9 cells/Liter
Standard Deviation 0.1401
|
|
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2
Blood monocytes, Follow-up, n=3, 2, 3
|
-0.093 10^9 cells/Liter
Standard Deviation 0.2558
|
-0.060 10^9 cells/Liter
Standard Deviation 0.1273
|
0.033 10^9 cells/Liter
Standard Deviation 0.0513
|
|
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2
Blood neutrophils, Day 2, n=24, 24, 24
|
-0.398 10^9 cells/Liter
Standard Deviation 0.8425
|
-0.520 10^9 cells/Liter
Standard Deviation 1.0250
|
-0.477 10^9 cells/Liter
Standard Deviation 0.8127
|
|
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2
Blood neutrophils, Follow-up, n=3, 2, 3
|
-0.350 10^9 cells/Liter
Standard Deviation 0.9560
|
-2.225 10^9 cells/Liter
Standard Deviation 0.0919
|
-0.563 10^9 cells/Liter
Standard Deviation 0.4179
|
|
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2
Blood platelets, Day 2, n=24, 24, 24
|
7.4 10^9 cells/Liter
Standard Deviation 15.81
|
12.9 10^9 cells/Liter
Standard Deviation 15.73
|
7.8 10^9 cells/Liter
Standard Deviation 14.96
|
|
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2
Blood platelets, Follow-up, n=3, 2, 3
|
18.0 10^9 cells/Liter
Standard Deviation 11.14
|
11.0 10^9 cells/Liter
Standard Deviation 29.70
|
12.3 10^9 cells/Liter
Standard Deviation 17.16
|
|
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2
Blood eosinophils, Follow-up, n=3, 2, 3
|
-0.060 10^9 cells/Liter
Standard Deviation 0.1253
|
0.015 10^9 cells/Liter
Standard Deviation 0.0778
|
-0.020 10^9 cells/Liter
Standard Deviation 0.0436
|
|
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2
Blood leukocytes, Day 2, n=24, 24, 24
|
-0.58 10^9 cells/Liter
Standard Deviation 0.925
|
-0.75 10^9 cells/Liter
Standard Deviation 1.097
|
-0.98 10^9 cells/Liter
Standard Deviation 1.208
|
SECONDARY outcome
Timeframe: Baseline and up to 36 days in Part 2Population: All Subjects Population
Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood hemoglobin results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x,x,x in the category titles)
Outcome measures
| Measure |
DTG 10 mg
n=24 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=24 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
n=24 Participants
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Change From Baseline in Hematology Parameter Blood Hemoglobin for Part 2
Blood hemoglobin, Day 2, n=24, 24, 24
|
5.0 g/L
Standard Deviation 5.56
|
6.3 g/L
Standard Deviation 5.12
|
4.8 g/L
Standard Deviation 6.65
|
|
Change From Baseline in Hematology Parameter Blood Hemoglobin for Part 2
Blood hemoglobin, Follow-up, n=3, 2, 3
|
3.7 g/L
Standard Deviation 5.69
|
2.0 g/L
Standard Deviation 5.66
|
3.7 g/L
Standard Deviation 2.31
|
SECONDARY outcome
Timeframe: Baseline and up to 36 days in Part 2Population: All Subjects Population
Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood hematocrit results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x,x,x in the category titles)
Outcome measures
| Measure |
DTG 10 mg
n=24 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=24 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
n=24 Participants
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Change From Baseline in Hematology Parameter Blood Hematocrit for Part 2
Blood hematocrit, Day 2, n=24, 24, 24
|
0.0126 Proportion of red blood cells in blood
Standard Deviation 0.01745
|
0.0172 Proportion of red blood cells in blood
Standard Deviation 0.01660
|
0.0158 Proportion of red blood cells in blood
Standard Deviation 0.01994
|
|
Change From Baseline in Hematology Parameter Blood Hematocrit for Part 2
Blood hematocrit, Follow-up, n=3, 2, 3
|
0.0113 Proportion of red blood cells in blood
Standard Deviation 0.02043
|
0.0090 Proportion of red blood cells in blood
Standard Deviation 0.01697
|
0.0103 Proportion of red blood cells in blood
Standard Deviation 0.00802
|
SECONDARY outcome
Timeframe: Baseline and up to 36 days in Part 2Population: All Subjects Population
Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood erythrocytes results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x,x,x in the category titles).
Outcome measures
| Measure |
DTG 10 mg
n=24 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=24 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
n=24 Participants
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Change From Baseline in Hematology Parameter Blood Erythrocytes for Part 2
Blood erythrocytes, Day 2, n=24, 24, 24
|
0.145 10^12 cells/Liter
Standard Deviation 0.2039
|
0.209 10^12 cells/Liter
Standard Deviation 0.1730
|
0.165 10^12 cells/Liter
Standard Deviation 0.2311
|
|
Change From Baseline in Hematology Parameter Blood Erythrocytes for Part 2
Blood erythrocyte, Follow-up, n=3, 2, 3
|
0.123 10^12 cells/Liter
Standard Deviation 0.2173
|
0.120 10^12 cells/Liter
Standard Deviation 0.1838
|
0.117 10^12 cells/Liter
Standard Deviation 0.0907
|
SECONDARY outcome
Timeframe: Up to 25 days in Part 1Population: All Subjects Population
Urinalysis parameters assessed were urine ketones, urine glucose, urine occult blood and urine protein. In this dipstick test, the level of ketones, glucose, occult blood and protein in urine samples was recorded as negative trace, 1+, 2+, and 3+ (the plus sign increases with a higher level of glucose, ketones, or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive). Urine samples were collected for the measurement of urinalysis parameters by dipstick method up-to follow-up (Day 25) in Part 1. Only categories with significant values have been presented.
Outcome measures
| Measure |
DTG 10 mg
n=14 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=14 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1
Urine Ketones, Trace, Day 2 (-24 hours)
|
2 Participants
|
2 Participants
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1
Urine Ketones, Trace, Follow-up
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1
Urine Occult Blood,Trace,Day 2 (-24 hours)
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1
Urine Occult Blood, 1+, Day 2 (-24 hours)
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1
Urine Occult Blood, 2+, Day 2 (-24 hours)
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1
Urine Occult Blood, 3+, Day 2 (-24 hours)
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1
Urine Protein, 3+, Day 2 (-24 hours)
|
1 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 25 days in Part 1Population: All Subjects Population
Urinary pH measurement is a routine part of urinalysis. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Urine samples were collected for the measurement of urine pH by dipstick method up-to follow-up (Day 25) in Part 1. Only categories with significant values have been presented. Only those participants with data available at the specified time were analyzed (represented by n=x,x in the category titles).
Outcome measures
| Measure |
DTG 10 mg
n=14 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=14 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Urine Potential of Hydrogen (pH) Analysis by Dipstick Method for Part 1
Urine pH, Day 2 (-24 hours), n=14,14
|
6.43 Points on a scale
Standard Deviation 0.703
|
6.25 Points on a scale
Standard Deviation 0.672
|
—
|
|
Urine Potential of Hydrogen (pH) Analysis by Dipstick Method for Part 1
Urine pH, Follow-up, n=5,5
|
6.20 Points on a scale
Standard Deviation 0.570
|
6.00 Points on a scale
Standard Deviation 0.612
|
—
|
SECONDARY outcome
Timeframe: Up to 25 days in Part 1Population: All Subjects Population
Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected for the measurement of urine specific gravity by dipstick method up-to follow-up (Day 25) in Part 1. Only categories with significant values have been presented. Only those participants with data available at the specified time were analyzed (represented by n=x,x in the category titles).
Outcome measures
| Measure |
DTG 10 mg
n=14 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=14 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Urine Specific Gravity Analysis by Dipstick Method for Part 1
Urine Specific Gravity,Day 2(-24 hours),n=14,14
|
1.0131 Ratio
Standard Deviation 0.00871
|
1.0177 Ratio
Standard Deviation 0.00752
|
—
|
|
Urine Specific Gravity Analysis by Dipstick Method for Part 1
Urine Specific Gravity,Follow-up,n=5,5
|
1.0180 Ratio
Standard Deviation 0.00831
|
1.0150 Ratio
Standard Deviation 0.01093
|
—
|
SECONDARY outcome
Timeframe: Up to 36 days in Part 2Population: All Subjects Population
Urinalysis parameters assessed were urine ketones, urine glucose, urine occult blood and urine protein. In this dipstick test, the level of ketones, glucose, occult blood and protein in urine samples was recorded as negative trace, 1+, 2+, and 3+ (the plus sign increases with a higher level of glucose, ketones, or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive). Urine samples were collected for the measurement of urinalysis parameters by dipstick method up-to follow-up (Day 36) in Part 2. Only categories with significant values have been presented.
Outcome measures
| Measure |
DTG 10 mg
n=24 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=24 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
n=24 Participants
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 2
Urine Ketones, Trace, Day 2 (-24 hours)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 2
Urine Occult Blood,Trace,Day 2 (-24 hours)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 2
Urine Occult Blood, 3+, Day 2 (-24 hours)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 2
Urine Occult Blood,1+ Follow-up,
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 2
Urine Protein, 1+, Day 2 (-24 hours)
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 36 days in Part 2Population: All Subjects Population
Urinary pH measurement is a routine part of urinalysis. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Urine samples were collected for the measurement of urine pH by dipstick method up-to follow-up (Day 36) in Part 2. Only categories with significant values have been presented. Only those participants with data available at the specified time were analyzed (represented by n=x,x,x in the category titles).
Outcome measures
| Measure |
DTG 10 mg
n=24 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=24 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
n=24 Participants
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Urine pH Analysis by Dipstick Method for Part 2
Urine pH, Follow-up, n=3, 2, 3
|
5.33 Points on a scale
Standard Deviation 0.289
|
5.50 Points on a scale
Standard Deviation 0.000
|
6.83 Points on a scale
Standard Deviation 0.577
|
|
Urine pH Analysis by Dipstick Method for Part 2
Urine pH, Day 2 (-24 hours), n=24, 24, 24
|
6.31 Points on a scale
Standard Deviation 0.586
|
6.21 Points on a scale
Standard Deviation 0.641
|
6.31 Points on a scale
Standard Deviation 0.528
|
SECONDARY outcome
Timeframe: Up to 36 days in Part 2Population: All Subjects Population
Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected for the measurement of urine specific gravity by dipstick method up-to follow-up (Day 36) in Part 2. Only categories with significant values have been presented. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Outcome measures
| Measure |
DTG 10 mg
n=24 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=24 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
n=24 Participants
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Urine Specific Gravity Analysis by Dipstick Method for Part 2
Urine Specific Gravity,Follow-up,n=3,2,3
|
1.0207 Ratio
Standard Deviation 0.00862
|
1.0165 Ratio
Standard Deviation 0.00354
|
1.0117 Ratio
Standard Deviation 0.00551
|
|
Urine Specific Gravity Analysis by Dipstick Method for Part 2
Urine Specific Gravity,Day 2(-24 hours),n=24,24,24
|
1.0143 Ratio
Standard Deviation 0.00636
|
1.0148 Ratio
Standard Deviation 0.00515
|
1.0141 Ratio
Standard Deviation 0.00674
|
SECONDARY outcome
Timeframe: Up to 25 days in Part 1Population: All Subjects Population
The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life threatening. low LDL (low-density lipid); HDL (high-density lipid). Data has been presented for clinical chemistry laboratory result parameter (serum sodium) with toxicity of Grade 2 for Part 1.
Outcome measures
| Measure |
DTG 10 mg
n=14 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=14 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Number of Participants With Chemistry Toxicities of Grade 2 as Defined by Division of Acquired Immunodeficiency Syndrome (DAIDS) for Part 1
|
1 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 25 days in Part 1Population: All Subjects Population
The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life threatening, low LDL and HDL Data has been presented for urinalysis laboratory result parameter (urine protein by dipstick analysis) with toxicity of Grade 2 for Part 1.
Outcome measures
| Measure |
DTG 10 mg
n=14 Participants
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=14 Participants
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 25 mg (Reference)
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|
|
Number of Participants With Urinalysis Toxicities of Grade 2 as Defined by DAIDS for Part 1
|
1 Participants
|
0 Participants
|
—
|
Adverse Events
DTG 10 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
DTG 50 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
DTG 5 mg (Test 1)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
DTG 5 mg (Test 2)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
DTG 25 mg (Reference)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DTG 10 mg
n=14 participants at risk
Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 50 mg
n=14 participants at risk
Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 5 mg (Test 1)
n=24 participants at risk
Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 1) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
DTG 5 mg (Test 2)
n=24 participants at risk
Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as direct to mouth (test 2) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses
|
DTG 25 mg (Reference)
n=24 participants at risk
Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/14 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
0.00%
0/14 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
4.2%
1/24 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
0.00%
0/24 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
0.00%
0/24 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/14 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
7.1%
1/14 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
0.00%
0/24 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
0.00%
0/24 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
0.00%
0/24 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/14 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
7.1%
1/14 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
0.00%
0/24 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
0.00%
0/24 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
0.00%
0/24 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
|
Nervous system disorders
Headache
|
0.00%
0/14 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
7.1%
1/14 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
0.00%
0/24 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
0.00%
0/24 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
0.00%
0/24 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
|
Psychiatric disorders
Abnormal dreams
|
7.1%
1/14 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
0.00%
0/14 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
0.00%
0/24 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
0.00%
0/24 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
0.00%
0/24 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/14 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
0.00%
0/14 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
4.2%
1/24 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
0.00%
0/24 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
0.00%
0/24 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/14 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
0.00%
0/14 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
0.00%
0/24 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
4.2%
1/24 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
0.00%
0/24 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
|
General disorders
Fatigue
|
0.00%
0/14 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
0.00%
0/14 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
0.00%
0/24 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
0.00%
0/24 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
4.2%
1/24 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
|
General disorders
Feeling jittery
|
0.00%
0/14 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
0.00%
0/14 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
4.2%
1/24 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
0.00%
0/24 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
0.00%
0/24 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/14 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
0.00%
0/14 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
0.00%
0/24 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
0.00%
0/24 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
4.2%
1/24 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/14 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
0.00%
0/14 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
0.00%
0/24 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
4.2%
1/24 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
0.00%
0/24 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/14 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
0.00%
0/14 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
0.00%
0/24 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
0.00%
0/24 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
4.2%
1/24 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/14 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
0.00%
0/14 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
0.00%
0/24 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
4.2%
1/24 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
0.00%
0/24 • AEs and SAEs were collected from the Day -1 up-to follow-up (25 days for Part 1 and 36 days for Part 2)
All Subjects Population was used for analysis of AEs and SAEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER