Adults 18 to 80, any sex, with Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Maximum Concentration (Cmax) of MK-6194Secondary· Predose on all days of dosing; 12, 24-48, and 120 hours (as available) post dose on the first and last day of dosing; and once each week up to approximately day 85.
Blood samples were collected at pre-specified time points to determine each participant's maximum concentration (Cmax). A participant's Cmax was defined as the maximum concentration of MK-6194 observed in serum over the entire course of the study for that individual and was calculated by taking the maximum over all observed MK-6194 serum concentrations. Geometric mean and geometric coefficient of variation of Cmax were calculated for each dosing group.
Group
Value
95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)
9.55
± 67.80
MK-6194 Medium Dose- Interval 2 (More Frequent)
30.02
± 95.85
MK-6194 High Dose - Interval 2 (More Frequent)
51.80
± 71.97
MK-6194 High Dose - Interval 1 (Less Frequent)
52.78
± 178.96
Time to Cmax (Tmax) of MK-6194Secondary· Predose on all days of dosing; 12, 24-48, and 120 hours (as available) post dose on the first and last day of dosing; and once each week up to approximately day 85
Blood samples were collected at pre-specified time points to determine maximum concentration (Cmax) of MK-6194 in each participant's serum and corresponding time of maximum concentration (Tmax). A participant's Tmax was defined as the time post-dose that the maximum concentration of MK-6194 was observed in serum. The median and range of Tmax were calculated for each dosing group.
Group
Value
95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)
12.00
11.10 – 24.00
MK-6194 Medium Dose- Interval 2 (More Frequent)
12.00
11.50 – 24.50
MK-6194 High Dose - Interval 2 (More Frequent)
12.05
11.10 – 25.00
MK-6194 High Dose - Interval 1 (Less Frequent)
12.10
11.20 – 12.20
Minimum Concentration (Cmin) of MK-6194Secondary· Predose on all days of dosing; 12, 24-48, and 120 hours (as available) post dose on the first and last day of dosing; and once each week up to approximately day 85
Blood samples were collected at pre-specified time points to determine the minimum concentration (Cmin) of MK-6194 present in each participant's serum. A participant's Cmin was defined as the minimum concentration of MK-6194 observed in serum over the entire course of the study for that individual and was calculated by taking the minimum over all observed MK-6194 serum concentrations. Geometric mean and geometric coefficient of variation of Cmin were calculated for each dosing group.
Group
Value
95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)
0.08
± 0.00
MK-6194 Medium Dose- Interval 2 (More Frequent)
0.08
± 0.00
MK-6194 High Dose - Interval 2 (More Frequent)
0.09
± 97.70
MK-6194 High Dose - Interval 1 (Less Frequent)
0.08
± 0.00
Apparent Half-life (t1/2) of MK-6194Secondary· Final day of dosing at 12, 24-48 hours, and 120 hours (as available) post-dose; from the last day of dosing once each week up to approximately day 85
Blood samples were collected at pre-specified time points to determine the apparent half-life (t1/2) of MK-6194. Noncompartmental analysis was used to calculate t1/2 for each participant using the terminal elimination phase after the final dose. Geometric mean and geometric coefficient of variation of t1/2 were calculated for each dosing group.
Group
Value
95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)
193.28
± 66.51
MK-6194 Medium Dose- Interval 2 (More Frequent)
52.84
± 23.89
MK-6194 High Dose - Interval 2 (More Frequent)
42.06
± 80.41
MK-6194 High Dose - Interval 1 (Less Frequent)
96.09
± 16.51
Apparent Clearance (CL/F) of MK-6194Secondary· Final day of dosing at 12, 24-48 hours, and 120 hours (as available) post-dose; from the last day of dosing once each week up to approximately day 85
Blood samples were collected at pre-specified time points to determine the apparent clearance (CL/F) of MK-6194 observed in serum. Noncompartmental analysis was used to calculate CL/F for each participant using the terminal elimination phase after the final dose. Geometric mean and geometric coefficient of variation of CL/F were calculated for each dosing group.
Group
Value
95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)
0.00
± 66.28
MK-6194 Medium Dose- Interval 2 (More Frequent)
0.01
± 82.72
MK-6194 High Dose - Interval 2 (More Frequent)
0.01
± 95.07
MK-6194 High Dose - Interval 1 (Less Frequent)
0.01
± 78.70
Apparent Volume of Distribution (Vd/F) of MK-6194Secondary· Final day of dosing at 12, 24-48 hours, and 120 hours (as available) post-dose; from the last day of dosing once each week up to approximately day 85
Blood samples were collected at pre-specified time points to determine the apparent volume of distribution (Vd/F) of MK-6194 observed in serum. Noncompartmental analysis was used to calculate Vd/F for each participant using the terminal elimination phase after the final dose. Geometric mean and geometric coefficient of variation of Vd/F were calculated for each dosing group.
Group
Value
95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)
1.61
± 121.12
MK-6194 Medium Dose- Interval 2 (More Frequent)
0.82
± 96.99
MK-6194 High Dose - Interval 2 (More Frequent)
0.55
± 226.96
MK-6194 High Dose - Interval 1 (Less Frequent)
0.81
± 93.17
Area Under the Concentration Time-curve From Time 0 to the Last Quantifiable Concentration (AUC0-t)Secondary· Predose on all days of dosing; 12, 24-48, and 120 hours (as available) post dose on the first and last day of dosing; and once each week up to approximately day 85
Blood samples were collected at pre-specified timepoints to determine the AUC0-t of MK-6194. AUC0-t is defined as the area under the concentration-time curve from time=0 (Day 1 predose) to the last quantifiable concentration. Noncompartmental analysis was used to calculate AUC0-t for each participant. Geometric mean and geometric coefficient of variation of AUC0-t were calculated for each dosing group.
Group
Value
95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)
955.51
± 39.92
MK-6194 Medium Dose- Interval 2 (More Frequent)
2080.46
± 55.64
MK-6194 High Dose - Interval 2 (More Frequent)
3546.54
± 67.17
MK-6194 High Dose - Interval 1 (Less Frequent)
3203.50
± 117.92
Area Under the Curve From Time 0 to Infinity (AUC0-inf) of MK-6194Secondary· Predose on all days of dosing; 12, 24-48, and 120 hours (as available) post dose on the first and last day of dosing; and once each week up to approximately day 85
Blood samples were collected at pre-specified timepoints to determine the AUC0-inf of MK-6194. AUC0-inf is defined as the area under the concentration-time curve from time=0 (Day 1 predose) to time=infinity. Noncompartmental analysis was used to calculate AUC0-inf for each participant; the portion of the AUC following the last observed concentration was assumed to follow an exponential elimination. Geometric mean and geometric coefficient of variation of AUC0-inf were calculated for each dosing group.
Group
Value
95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)
899.08
± 36.53
MK-6194 Medium Dose- Interval 2 (More Frequent)
2036.51
± 71.46
MK-6194 High Dose - Interval 2 (More Frequent)
3437.33
± 65.59
MK-6194 High Dose - Interval 1 (Less Frequent)
3169.11
± 120.37
Change in Number of Peripheral Regulatory T-cells (Tregs) in Whole BloodSecondary· Pre-dose (baseline) and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Blood samples were collected at pre-specified time points and analyzed by flow cytometry. The absolute change in the number of peripheral Tregs in whole blood was assessed.
Week 1
Group
Value
95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)
16.6
± 46.10
MK-6194 Medium Dose- Interval 2 (More Frequent)
24.0
± 130.34
MK-6194 High Dose - Interval 2 (More Frequent)
36.5
± 76.68
MK-6194 High Dose - Interval 1 (Less Frequent)
31.0
± 48.95
Placebo
0.0
± 107.20
Week 2
Group
Value
95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)
15.2
± 45.43
MK-6194 Medium Dose- Interval 2 (More Frequent)
8.4
± 78.56
MK-6194 High Dose - Interval 2 (More Frequent)
0.0
± 84.52
MK-6194 High Dose - Interval 1 (Less Frequent)
29.8
± 100.53
Placebo
6.0
± 109.31
Week 3
Group
Value
95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)
12.2
± 113.83
MK-6194 Medium Dose- Interval 2 (More Frequent)
24.5
± 95.40
MK-6194 High Dose - Interval 2 (More Frequent)
31.7
± 92.24
MK-6194 High Dose - Interval 1 (Less Frequent)
15.2
± 77.36
Placebo
4.4
± 96.26
Week 4
Group
Value
95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)
5.1
± 71.20
MK-6194 Medium Dose- Interval 2 (More Frequent)
9.5
± 78.31
MK-6194 High Dose - Interval 2 (More Frequent)
12.8
± 82.29
MK-6194 High Dose - Interval 1 (Less Frequent)
4.8
± 115.02
Placebo
0.0
± 120.87
Week 5
Group
Value
95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)
33.9
± 61.55
MK-6194 Medium Dose- Interval 2 (More Frequent)
0.0
± 66.63
MK-6194 High Dose - Interval 2 (More Frequent)
20.9
± 78.63
MK-6194 High Dose - Interval 1 (Less Frequent)
35.5
± 65.56
Placebo
0.0
± 92.71
Week 6
Group
Value
95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)
9.0
± 32.73
MK-6194 Medium Dose- Interval 2 (More Frequent)
12.9
± 73.27
MK-6194 High Dose - Interval 2 (More Frequent)
9.8
± 100.16
MK-6194 High Dose - Interval 1 (Less Frequent)
18.9
± 58.45
Placebo
0.0
± 61.81
Week 7
Group
Value
95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)
4.0
± 53.29
MK-6194 Medium Dose- Interval 2 (More Frequent)
32.3
± 44.51
MK-6194 High Dose - Interval 2 (More Frequent)
27.1
± 69.98
MK-6194 High Dose - Interval 1 (Less Frequent)
7.4
± 130.11
Placebo
0.0
± 66.82
Week 8
Group
Value
95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)
3.9
± 25.00
MK-6194 Medium Dose- Interval 2 (More Frequent)
9.4
± 101.40
MK-6194 High Dose - Interval 2 (More Frequent)
8.8
± 62.20
MK-6194 High Dose - Interval 1 (Less Frequent)
7.7
± 101.49
Placebo
0.0
± 102.85
Change in Number of Natural Killer (NK) Cells in Whole BloodSecondary· Pre-dose (baseline) and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Blood samples were collected at pre-specified time points and analyzed by flow cytometry. The change in the number of NK cells in whole blood is presented.
Week 1
Group
Value
95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)
109.3
± 117.56
MK-6194 Medium Dose- Interval 2 (More Frequent)
0.0
± 149.43
MK-6194 High Dose - Interval 2 (More Frequent)
43.2
± 86.39
MK-6194 High Dose - Interval 1 (Less Frequent)
110.0
± 61.90
Placebo
34.40
± 60.38
Week 2
Group
Value
95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)
124.7
± 83.32
MK-6194 Medium Dose- Interval 2 (More Frequent)
76.1
± 62.77
MK-6194 High Dose - Interval 2 (More Frequent)
48.6
± 81.20
MK-6194 High Dose - Interval 1 (Less Frequent)
108.5
± 55.48
Placebo
19.2
± 160.68
Week 3
Group
Value
95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)
479.5
± 85.51
MK-6194 Medium Dose- Interval 2 (More Frequent)
50.3
± 73.79
MK-6194 High Dose - Interval 2 (More Frequent)
44.2
± 110.61
MK-6194 High Dose - Interval 1 (Less Frequent)
68.4
± 62.20
Placebo
64.1
± 87.37
Week 4
Group
Value
95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)
292.2
± 48.38
MK-6194 Medium Dose- Interval 2 (More Frequent)
52.8
± 67.48
MK-6194 High Dose - Interval 2 (More Frequent)
0.0
± 102.83
MK-6194 High Dose - Interval 1 (Less Frequent)
78.9
± 73.40
Placebo
42.1
± 131.09
Week 5
Group
Value
95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)
281.5
± 27.43
MK-6194 Medium Dose- Interval 2 (More Frequent)
42.1
± 76.34
MK-6194 High Dose - Interval 2 (More Frequent)
53.8
± 61.16
MK-6194 High Dose - Interval 1 (Less Frequent)
133.2
± 87.96
Placebo
65.0
± 129.61
Week 6
Group
Value
95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)
169.0
± 88.11
MK-6194 Medium Dose- Interval 2 (More Frequent)
59.3
± 72.56
MK-6194 High Dose - Interval 2 (More Frequent)
54.7
± 80.71
MK-6194 High Dose - Interval 1 (Less Frequent)
140.3
± 78.10
Placebo
55.3
± 124.75
Week 7
Group
Value
95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)
224.8
± 83.09
MK-6194 Medium Dose- Interval 2 (More Frequent)
0.0
± 112.85
MK-6194 High Dose - Interval 2 (More Frequent)
73.2
± 66.16
MK-6194 High Dose - Interval 1 (Less Frequent)
82.0
± 93.62
Placebo
44.9
± 119.10
Week 8
Group
Value
95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)
272.9
± 54.62
MK-6194 Medium Dose- Interval 2 (More Frequent)
38.4
± 113.46
MK-6194 High Dose - Interval 2 (More Frequent)
43.7
± 148.37
MK-6194 High Dose - Interval 1 (Less Frequent)
86.9
± 49.10
Placebo
30.4
± 125.05
Change in Number of Conventional T Cells (Tcons) in Whole BloodSecondary· Pre-dose (baseline) and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Blood samples were collected at pre-specified time points and analyzed by flow cytometry. The change in the number of Tcons in whole blood is presented.
Week 1
Group
Value
95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)
216.9
± 94.52
MK-6194 Medium Dose- Interval 2 (More Frequent)
220.8
± 94.37
MK-6194 High Dose - Interval 2 (More Frequent)
91.2
± 105.12
MK-6194 High Dose - Interval 1 (Less Frequent)
189.6
± 66.58
Placebo
57.6
± 79.00
Week 2
Group
Value
95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)
106.1
± 124.15
MK-6194 Medium Dose- Interval 2 (More Frequent)
100.8
± 67.50
MK-6194 High Dose - Interval 2 (More Frequent)
105.4
± 121.23
MK-6194 High Dose - Interval 1 (Less Frequent)
184.1
± 67.77
Placebo
0.0
± 71.58
Week 3
Group
Value
95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)
347.3
± 129.76
MK-6194 Medium Dose- Interval 2 (More Frequent)
81.1
± 98.95
MK-6194 High Dose - Interval 2 (More Frequent)
123.7
± 111.06
MK-6194 High Dose - Interval 1 (Less Frequent)
192.8
± 60.55
Placebo
127.7
± 52.96
Week 4
Group
Value
95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)
280.2
± 116.12
MK-6194 Medium Dose- Interval 2 (More Frequent)
122.4
± 61.71
MK-6194 High Dose - Interval 2 (More Frequent)
73.3
± 108.47
MK-6194 High Dose - Interval 1 (Less Frequent)
163.4
± 72.06
Placebo
63.3
± 105.58
Week 5
Group
Value
95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)
456.3
± 28.23
MK-6194 Medium Dose- Interval 2 (More Frequent)
100.6
± 74.36
MK-6194 High Dose - Interval 2 (More Frequent)
126.2
± 75.69
MK-6194 High Dose - Interval 1 (Less Frequent)
166.8
± 76.19
Placebo
79.3
± 66.49
Week 6
Group
Value
95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)
114.3
± 119.18
MK-6194 Medium Dose- Interval 2 (More Frequent)
57.9
± 101.25
MK-6194 High Dose - Interval 2 (More Frequent)
0.0
± 101.48
MK-6194 High Dose - Interval 1 (Less Frequent)
193.9
± 68.59
Placebo
53.8
± 90.84
Week 7
Group
Value
95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)
137.7
± 84.27
MK-6194 Medium Dose- Interval 2 (More Frequent)
103.6
± 68.22
MK-6194 High Dose - Interval 2 (More Frequent)
68.6
± 87.88
MK-6194 High Dose - Interval 1 (Less Frequent)
154.5
± 70.64
Placebo
66.1
± 87.17
Week 8
Group
Value
95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)
381.1
± 34.64
MK-6194 Medium Dose- Interval 2 (More Frequent)
109.0
± 84.28
MK-6194 High Dose - Interval 2 (More Frequent)
63.5
± 82.18
MK-6194 High Dose - Interval 1 (Less Frequent)
159.1
± 66.12
Placebo
50.6
± 93.80
Titer of Anti-drug Antibody (ADA) to MK-6194Secondary· Pre dose (week 0) and Weeks 4, 8, 12
Blood samples were collected for the determination of ADA to MK-6194 using a screening assay, ADA titer using a confirmatory assay, and neutralizing antibody to MK-6194 in participants with confirmed positive titers
Week 0
Group
Value
95% CI
MK-6194 Medium Dose- Interval 2 (More Frequent)
20.0
20.0 – 20.0
MK-6194 High Dose - Interval 1 (Less Frequent)
20.0
20.0 – 20.0
Week 4
Group
Value
95% CI
MK-6194 Medium Dose- Interval 2 (More Frequent)
20.0
20.0 – 20.0
MK-6194 High Dose - Interval 2 (More Frequent)
20.0
20.0 – 20.0
MK-6194 High Dose - Interval 1 (Less Frequent)
20.0
20.0 – 160.0
Week 8
Group
Value
95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)
160.0
160.0 – 160.0
MK-6194 Medium Dose- Interval 2 (More Frequent)
20.0
20.0 – 20.0
MK-6194 High Dose - Interval 2 (More Frequent)
20.0
20.0 – 20.0
MK-6194 High Dose - Interval 1 (Less Frequent)
20.0
20.0 – 40.0
Week 12
Group
Value
95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)
640.0
640.0 – 640.0
MK-6194 Medium Dose- Interval 2 (More Frequent)
40.0
20.0 – 320.0
MK-6194 High Dose - Interval 2 (More Frequent)
20.0
20.0 – 640.0
MK-6194 High Dose - Interval 1 (Less Frequent)
40.0
20.0 – 160.0
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to approximately 52 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
IBT: MK-6194 Low Dose Interval 1 (Less Frequent)
Serious: 1/7 (14%)
Deaths: 0/7
IBT-MK-6194 Medium Dose- Interval 2 (More Frequent)
Serious: 0/11 (0%)
Deaths: 0/11
IBT: MK-6194 High Dose-Interval 2 (More Frequent)
Serious: 1/18 (6%)
Deaths: 0/18
IBT:MK-6194 High Dose-Interval 1 (Less Frequent)
Serious: 0/10 (0%)
Deaths: 0/10
IBT: Placebo
Serious: 0/11 (0%)
Deaths: 0/11
CBT: MK-6194 Low Dose- Interval 1 (Less Frequent)
Serious: 0/2 (0%)
Deaths: 0/2
CBT: MK-6194 Medium Dose- Interval 2 (More Frequent)
Serious: 0/1 (0%)
Deaths: 0/1
CBT: MK-6194 High Dose- Interval 2 (More Frequent)
Serious: 0/2 (0%)
Deaths: 0/2
CBT: MK-6194 High Dose - Interval 1 (Less Frequent)
Serious: 0/3 (0%)
Deaths: 0/3
CBT: Placebo
Serious: 0/3 (0%)
Deaths: 0/3
OL: MK-6194 Low Dose -Interval 1 (Less Frequent)
Serious: 0/3 (0%)
Deaths: 0/3
OL: MK-6194 Medium Dose- Interval 2 (More Frequent)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of MK-6194 in participants with active UC.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06821334 — A Single Dose Study of MK-6194 in Healthy Chinese Participants (MK-6194-014)
· Phase 1
· completed
NCT06161116 — Efficacy And Safety Of MK-6194 In Adult Participants With Systemic Lupus Erythematosus (MK-6194-006)
· Phase 2
· terminated
NCT06113328 — A Clinical Study of MK-6194 for the Treatment of Vitiligo (MK-6194-007)
· Phase 2
· terminated
NCT06649877 — MK-6194 Site of Injection Study in Healthy Adult Participants (MK-6194-013)
· Phase 1
· completed
NCT05450198 — Multiple Rising Dose Study of MK-6194 in Participants With Atopic Dermatitis (MK-6194-008)
· Phase 1
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 29 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04924114.